The mean cognitive and behavioral outcomes for children aged 9 years who had prenatal exposure to their mother’s cancer were within normal ranges and comparable to the general population, at a long-term follow-up published in the 

Full scale intelligence quotient (FSIQ) was not found to be different by cancer treatment types (

 = .802) were found to have a significant impact. Moreover, for children who were exposed to therapy (n = 109), no associations between the FSIQ and chemotherapeutic agent, exposure level, or timing of treatment emerged.

On average, the FSIQ score increased by 1.6 points for each week increase in gestational age at birth (95% CI, 0.7-2.5; 

“Cognitive and behavioral outcomes of 9-year-old children born to mothers diagnosed with cancer during pregnancy did not differ with norms of the general population,” wrote Indra A. Van Assche, MSc, a PhD researcher in neuropsychology at the University of Leuven, in Leuven, Belgium, and co-investigators, in the study. “We reported average group scores for all intelligence index scores, verbal and visuospatial memory outcomes, attentional functioning outcomes, and behavioral questionnaire measures. We found no impact of sex, treatment type, and cancer stage.”

Previous reports from this study suggested that fetal exposure to chemotherapy was not associated with increased central nervous system, cardiac or auditory morbidity and that the impairments that these children faced in regard to their general health and growth were comparable to the general population.

 At the same time, subtle changes in cardiac and neurocognitive measurements emphasized the importance of long-term follow-up. In this analysis premature birth was the greatest driver of cognitive development impairments.

In total, investigators used neurocognitive tests and parent-reported behavioral questionnaires to assess 151 children (mean age, 9.3 years; range, 7.8-10.6), including 96 from Belgium, 24 from the Netherlands, 9 from Italy, 6 from the Czech Republic, and 7 from New Jersey. In this set of participants, 109 (72.2%) had been exposed to chemotherapy (alone or combination with other treatment modalities), 18 (11.9%) had surgery alone, 16 (10.6%) had been expressed to radiotherapy, 1 to trastuzumab (Herceptin), and 16 (10.6%) had not been exposed to cancer treatment.

As part of the International Network on Cancer, Infertility and Pregnancy Child Follow-up study, children were assessed longitudinally at the age of 18 months, 36 months, and again every 3 years until age 18. This current 9-year analysis used FISQ, which is derived from the Wechsler Intelligence Scale for Children. Secondary outcomes were neurocognitive test scores and behavioral questionnaire results. All children also underwent a clinical neurologic and general pediatric examinations, and parents filled out a survey regarding their children general health and education level. All tests were conducted in the child’s native language.

Of note, gestational age at birth did show a positive association with full FISQ. Observations were also observed with maternal death and maternal education.

Gestational age was linked to verbal intelligence (β, 1.49 points/week; CI, 0.6-2.4; 

= .02), performance intelligence (β, 1.39 points/week; CI, 0.6-2.2; 

 = .002), and processing speed (β, 1.21 points/week; CI, 0.3-2.1; 

Moreover, maternal bereavement was linked to lower FSIQ scores (

 = .022). Children whose mothers passed away before they age 2 years demonstrated lower FSIQs (93.13 ± 12.65) than those with a surviving mother (104.08 ± 14.88). However, adjustments for gestational age caused this association to disappear (

 < .3). Of note, children whose mother passed away before they were 2 years were, on average, born earlier (33.4 weeks ± 2.7), than those whose mother passed away after they were 2 years (37.1 weeks ± 1.7) and those with a surviving mother at the time of follow-up (36.4 weeks ± 2.5; 

In terms of general health, the patient-reported health questionnaire revealed no specific group across the population. Four children had been diagnosed with attention-deficit hyperactivity disorder, 3 of whom needed supportive medication. One child was on the autistic spectrum. Thirty-one children (24.4%) received remedial care, including speech therapy (n = 17), remedial teaching at school (n = 10), a type of physical or exercise therapy (n = 4), and neurofeedback therapy (n = 1).

Study authors noted that maternal death was not associated with not associated with a specific cancer type, cancer stage, or treatment type in this study and that, therefore, children who consequently developed cognitive development problems may have been equally affected by the maternal stress or an insecure mother-child attachment as they were by treatments. Moreover, for children who were prenatally exposed to chemotherapy, maternal education level was the only driving factor in FSIQ scores; prematurity was not found to have an effect, suggesting that more research into the effect of prematurity may be warranted in a larger chemotherapy group.

“Seventeen percent of the children in this study had lost their mother (of which almost 58% died before their child turned 2 years old),” study authors concluded. “The results suggest a relationship between maternal bereavement in the first 1000 days of life and full-scale intelligence, although a larger sample is necessary to disentangle effects of maternal loss and often coinciding premature birth.”

In accordance with the study guidelines, follow-up with this group of children will continue to be ongoing until they are age 18 years.

Van Assche IA, Huis In 't Veld EA, Van Calsteren K, et al. Cognitive and behavioral development of 9-year-old children after maternal cancer during pregnancy: a prospective multicenter cohort study. 

. Published online January 12, 2023. doi:10.1200/JCO.22.02005

Amant F, Van Calsteren K, Halaska MJ, et al: Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: An observational study. 

 2012;13(3):256-264. doi:10.1016/S1470-2045(11)70363-1

Articles

An analysis of 141 children who had prenatal exposure to maternal cancer showed promising cognitive and behavioral functions at age 9 years. 

Children Exposed to Maternal Cancer Show Normal Cognitive and Behavioral Outcomes

Pain management is a core component of cancer care. However, use of agents to curb these effects, especially opioids present challenges in practice including stigma around opioid abuse, reimbursement issues, lack of availability, and patient fear of addiction. The American Society of Clinical Oncology (ASCO) has updated its guidelines providing recommendations for the management of cancer pain with opioids.

Approximately 55% of patients experience pain during active cancer treatment and more than 66% of patients with advanced disease will experience cancer-related pain. Although guidelines for managing cancer-related pain exist, there are few guidelines focused on exclusively on opioids. Opioids approved by the FDA are viable options for pain relief and use should be determined based on several factors including cost, half-life, pharmacokinetic properties, and route of administration. If a clinician is unsure of the best agent palliative care or pain specialists should be consulted.

A multidisciplinary expert panel consisting of patient representatives and an ASCO guidelines staff member with health research methodology expertise developed the guidelines that were informed by evidence including 16 randomized controlled trials and 31 systemic reviews from January 1, 2010, to February 17, 2022.

The supportive care guidelines addressed 7 key questions for patients with cancer pain under all of which fell under the umbrella of the leading question: “In what circumstances should opioids be used to manage cancer pain in adults, how should opioids be administered, and how should opioid adverse effects be prevented or managed?”

Regarding the circumstances under which opioids should be offered, an evidence-based strong recommendation was given by the panel that all patients with moderate-to-severe pain related to cancer or active treatments should be offered, unless otherwise determined, opioids to be given as needed as the benefits outweigh the harm. According to informal consensus, opioids should be administered at the lowest possible dose, early assessment and titration should occur as well; however, there is insufficient evidence to recommend a single set of ranges for escalation. The authors wrote, “In general, the minimum dose increase is 25% [to] 50%, but patient factors such as frailty, comorbidities, and organ function must be evaluated and considered when changing doses.”

In terms of opioid-induced adverse event (AE) management, the panel noted several events with recommendations for prevention and treatment. These events included constipation, delirium and neurotoxicity, endocrinopathy, nausea and vomiting, pruritus, sedation and respiratory depression, and urinary retention. Guidelines for opioid-induced constipation have been published and should be referenced.

 All others should be treated based on clinical experience.

The guidelines advised that patients with renal or hepatic impairment should receive more frequent dose adjustments and clinical observations. Patients with renal impairment who are currently undergoing treatment with an opioid may rotate to methadone as it is excreted fecally. For those who are given opioids that are primarily eliminated in urine, such as fentanyl, oxycodone, and hydromorphone, careful titration, and frequent risk monitoring for accumulation of the parent drug or active metabolites should occur. Both recommendations are supported by strong informal consensus.

Additional recommendations stated that patients who have been taking other analgesics such as nonsteroidal anti-inflammatory drugs, may continue taking them after initiating opioid use if they provide further pain relief. However, there is insufficient evidence on a set range for dose escalation and whether genetic testing should be performed to guide administration of opioids.

The panel noted that there is insufficient evidence to provide a recommendation for a specific short-acting opioid for breakthrough pain, but patients receiving opioids around the clock should be given immediate release agents at a dose of 5% to 20% of the daily regular morphine equivalent daily dose for breakthrough pain. As with the titration recommendation, there is insufficient evidence to support a specific opioid for breakthrough pain.

A strong evidence-based recommendation for opioid rotation is included in the guideline. Specifically, the evidence supports switching agents when AEs are poorly managed, there are logistical or cost concerns, trouble with the route of administration or absorption of an opioid, or patients have pain that is refractory to dose titration. As with the titration recommendation, there is insufficient evidence to support a specific opioid for breakthrough pain.

The guidelines also stated that because patients with multiple chronic conditions represent a diverse and complex population shared decision making is crucial and clinicians should review all chronic conditions present when determining a treatment plan. It was noted that patients with persistent noncancer pain who were already being treated with opioids and later developed cancer, may have a challenging time obtaining pain relief.

Prior to prescribing opioids, physicians, patients, and caregivers should discuss expectations, goals, pain, and concerns about the treatment; education as well as regular follow-up is key between clinicians and patients. Shared decision-making should also take cost into account and patients should be informed of financial counseling services. To prevent or manage AEs to opioid use, education, and strategies of prevention to known effects should be given by clinicians.

As there are few guidelines focused solely on opioids for pain management, evidence for several of the questions was limited leading the panel to reply on consensus or they could not make a recommendation; however, the panel noted that the use of opioids for cancer pain management has been routine. The panel recommended that to determine the best approach of pain management for patients with a substance use disorder, clinicians should discuss with a palliative care, pain, and/or substance abuse disorder specialist.

A draft of the recommendations was made available to the public for comment from July 8, 2022, through July 22, 2022, and for each recommendation, 88% to 100% of respondents agreed or agreed with slight modifications. Additionally, ASCO noted that most randomized controlled trials included in the analysis had an intermediate or high risk of bias and further questions remain about the use of opioids for cancer pain management.

Paice JA, Bohlke K, Barton D, et al. Use of opioids for adults with pain from cancer or cancer treatment: ASCO guideline. 

. Published online December 5, 2022. doi:10.1200/JCO.22.02198

Larkin PJ, Cherny NI, La Carpia D, et al; ESMO Guidelines Committee. Diagnosis, assessment and management of constipation in advanced cancer: ESMO clinical practice guidelines. 

. 2018;29(suppl 4):iv111-iv125. doi:10.1093/annonc/mdy148

The American Society of Clinical Oncology (ASCO) has updated its guidelines providing recommendations for the management of cancer pain with opioids.

ASCO Guidelines Provide Road Map for Cancer Pain Management With Opioids 

Sunitinib (Sutent) was the most cost-effective immunotherapy treatment option for patients with metastatic renal cell carcinoma (mRCC) in an analysis of the drug and other approved immunotherapy (IO)/IO-tyrosine kinase inhibitor (TKI) drug combinations using public payer acquisition costs in the United States. Notably, nivolumab (Opdivo) plus ipilimumab (Yervoy) was deemed the most effective treatment option in the model but did not meet the willingness-to-pay threshold (WTP).

Sunitinib was ranked as the least expensive treatment in the model. Its costs were estimated to be between $357,948 USD and $656,100 USD across a 10-year span. Lenvatinib (Lenvima) plus pembrolizumab (Keytruda) or pembrolizumab plus axitinib (Inlyta) were ranked as the most expensive (range, $959,302 USD-$1,403,671 USD). Nivolumab plus ipilimumab garnered the highest number of quality-of-life years (QALYs; 3.6) and avelumab (Bavenzio) plus axitinib procured the least number of QALYs (2.5).

“Our results demonstrate that sunitinib was the most cost-effective first-line strategy at a WTP of $150,000 USD/QALY, which is the threshold typically used by the US Institute for Clinical and Economic Research because of lower drug-associated costs compared with all other approved IO-IO and IO-TKI combinations,” wrote Minkyoung Yoo, PhD, of the University of Utah Health Systems, and co-investigators, in the study. “Among combination therapies, [nivolumab plus ipilimumab] was the only strategy not dominated by sunitinib. [Nivolumab plus ipilimumab] was associated with higher QALYs over a 10-year time horizon vs all other options including sunitinib.”

In the United States, the estimated incidence of renal cell cancer for 2022 was 79,000, resulting in approximately 13,900 deaths. Significant advances have been made to treat this disease, including numerous immunotherapies and IO-based drug combinations, including combinations with TKIs. These treatments have demonstrated significant improvements in response rates, progression-free survival (PFS), and overall survival (OS). However, it is important to note the rates of immune-related adverse events (irAEs), which can affect overall treatment costs and therefore warrant financial considerations. In 1 systematic review of patients with urologic cancers who received immunotherapy or IO-TKI combination therapy, the rate of any-grade treatment-related AEs was 88.3%, including an any-grade irAE rate of 42.7%.

Investigators designed a decision model with a 10-year time horizon. They included 7 different treatment strategies; these were atezolizumab (Tecentriq) plus bevacizumab (Avastin); avelumab plus axitinib; pembrolizumab plus axitinib, nivolumab plus ipilimumab, nivolumab plus cabozantinib (Cometriq), lenvatinib plus pembrolizumab, and sunitinib alone. These treatments were measured in terms of QALYs with utility values, based on the published literature. The costs include the drug acquisition costs along with the management of grade 3 or 4 drug-related adverse events.

Study authors noted that with a higher willingness-to-pay threshold, nivolumab/ipilimumab would be the most cost-effective. These results were consistent across the VA Federal Supply Schedule Service (VA FSS) and the National Average Drug Acquisition Cost (NADAC) drug costs, and whether patients were assumed to receive second-line therapy after the failure of first-line treatment.

The model included a partitioned survival model, in which patients transitioned between 3 health states, progression-free, progressive disease, and death, at monthly intervals, on the basic of parametric survival function. There were estimated from published survival curves. Cost-effectiveness was determined by incremental cost-effectiveness ratios (ICERs) by dividing the difference in cost by the difference in effectiveness between nondenominated treatments.

Regardless of the perspective and the rate of subsequent therapy, sunitinib demonstrated the lowest 10-year total costs at $467,394 USD to $726,068 USD (including medications, administration costs, and drug-related adverse events), whereas lenvatinib/pembrolizumab or pembrolizumab/axitinib showed the highest (range, $1,116,302 USD-$1,502,129).

The estimated 10-year QALYs ranged from 2.52 for avelumab/axitinib to 3.60 years with nivolumab plus ipilimumab. Atezolizumab plus bevacizumab, avelumab plus axitinib, nivolumab plus cabozantinib, lenvatinib/pembrolizumab, and pembrolizumab/axitinib were not considered in this part of the analysis because they were both less effective and more expensive than sunitinib alone, and nivolumab/ipilimumab, or a linear combination of both treatments.

The incremental cost-effectiveness ratio for nivolumab/ipilimumab, was from $297,465 USD per QALY in a model where 30% of patients were receiving second-line therapy and the V FSS was used for pricing, to $422,220 USD/QALY in a version where all patients were Medicare/Medicaid beneficiaries and were receiving second-line therapy.

According to study authors, this study differs from other publish cost-effective analyses for mRCC, including Shay et al, which deemed nivolumab/ipilimumab to be most cost-effective, but did not include sunitinib as a comparator.3 One key difference with this study is that it used the NADAC and VA FSS to determine drug prices, whereas many other published analyses used the manufacturers’ list price, which does not include discounts and rebates. Moreover, this study ran a version of the model in which all patients received second-line therapy, as well a version in which only 30% did, they also included a total of all 7 first-line approved treatments, rather than a subset of therapies.

The study authors acknowledged that extrapolating survival data to a 10-year time horizon invites uncertainty. Although they tested various potential parametric survival functions, used 6 independent clinical trials to compare each IO-TKI combination against sunitinib, this uncertainty may still be present. Moreover, the Kaplan-Meier PFS and OS curves for sunitinib vary across each of these studies. Consequently, investigators used both the highest and lowest reported median PFS time from the 6 trials. 

Finally, although the VA FSSS and Average Sales Price/NADAC may represent the actual drugs costs better than the wholesale acquisitions, study authors acknowledge that drug prices still very greatly across payers in the United States—and the study did not include out-of-pocket costs.

Yoo M, Nelson RE, Cutshall Z, Dougherty M, Kohli M. Cost-effectiveness analysis of six immunotherapy-based regimens and sunitinib in metastatic renal cell carcinoma: a public payer perspective. 

. Published online January 4, 2023. doi:10.1200/OP.22.00447

Wu Z, Chen Q, Qu L, et al. Adverse events of immune checkpoint inhibitors therapy for urologic cancer patients in clinical trials: a collaborative systematic review and meta-analysis. 

 2022;81(4):414-425. doi:10.1016/j.eururo.2022.01.028

Shay RC, Nicklawsky A, Lam ET. Comparative effectiveness of combination first-line therapies for metastatic renal cell carcinoma (mRCC).

. 2021;39 (suppl 15):e16549. doi:10.1200/JCO.2021.39.15_suppl.e16549

A decision model with a 10-year time horizon found that nivolumab plus ipilimumab was the most effective combination for patients with metastatic renal cell carcinoma, but sunitinib was the most cost-effective approach. 

Nivolumab/Ipilimumab May Be Most Effective mRCC Treatment, Sunitinib Most Cost-Effective

In the age of social media, misinformation of all kinds is now more easily spread than ever, whether it is intentionally spread or not. Unfortunately, misinformation about cancer is no exception. Although most false information may seem obviously fake to those in the health care industry, it can be hard for the average person to discern fact from fiction. For patients who are scared of their cancer growing or recurring, taking matters of research into their own hands is often an intuitive choice. Therefore, conversations about misinformation are becoming increasingly relevant.

There are many different myths and unproven claims related to cancer—causes, ways to prevent it, and alleged cures alike. A few of the most common specific claims include the following:

Aluminum-based antiperspirants cause breast cancer.

Eating sugar “feeds” cancer and causes it to grow.

Cancer can be cured by eating a particular diet (e.g., Gerson therapy

) or cured by consuming particular herbs or supplements (e.g., Vitamin C infusions alone,

All of the above claims, along with many others, have either been proven false, oversimplify a complex or unclear cause-effect or, in most cases, have insufficient information to establish as either true or false. Ambiguity and misleading personal anecdotes can make it easier for misinformation to spread.

There are a few important things providers can do to better support patients who have concerns about lifestyle, environmental risks, or potential alternative therapies.

 It is imperative to appreciate the perspective of a patient who is concerned about their cancer risks. Many patients do not know how or why their cancer developed. This lack of known cause and effect can often be emotionally destabilizing, as the trust they had in their bodies is now broken. Those worried about future cancer risk are often motivated to maximize their chances either of curing their present cancer or preventing a future diagnosis. Oncology workers can create a safe, nonjudgmental space for patients to voice their questions or concerns about potentially false cancer information they’ve learned through social media or well-meaning loved ones. These professionals can empathize with the fear and confusion that contradicting information can create, especially for the cancer patient with a course of treatment already underway. Building this rapport will allow the patient to feel more comfortable bringing up additional concerns in the future, both relating to popular cancer claims and in general.

Provide any available, accurate information.

 When health care providers come from a place of empathy and understanding, they are able to empower clients with accurate health information. The 

 all have excellent online resources that discuss the truthfulness of many common myths and claims. Create time to compare treatment methods that are already fully evidence-based and FDA-approved vs other methods that may have the potential to be helpful but are not yet adequately researched. This can help patients fully understand if, how, or why a treatment may work. Although it is important to empower patients to make their own choices, it would be negligent for any health care professional to allow patients to make uninformed decisions.

When helping patients learn how to better identify potential misinformation, there are a few questions for patients to ask when assessing a claim for validity, whether a social media post, article, or other means of communication.

Does the individual presenting this information have any professional background in cancer or cancer research? If the post was not written by a specific person, is there an organization connected to the post? Is this organization known within the cancer community to be a reputable source of information?

Is the individual or online post appealing to your emotions?

 Appealing to emotions is a common tactic among those who purposely spread misinformation. Research suggests that those who rely on emotion over reason are more likely to believe false information.

Does the individual or post cite a source, or do they rely on personal anecdote? 

When a loved one offers a suggestion, it may be easier to take them at their word due to established trust. But even outside of that personal relationship, it’s important to know where they learned such information as they too may have picked up false information.

What motivation does the source have to share this information with you?

 Although most individuals share information in good faith, others may have a more selfish reason to convince you of certain information. Unfortunately, there are those that use sickness of all kinds, including cancer, for personal financial gain or to collect personal information.

Additional information on deciphering cancer information online or through social media can be found on National Cancer Institute’s website 

 also offers a library of resources about 

how a person can talk to their medical team

 social worker can also help break down information patients are seeing online and navigate them to verified information outlets.

1. Antiperspirants/deodorants and breast cancer. National Cancer Institute. August 9, 2016. Accessed November 29, 2022. 

1. Does sugar feed cancer? Dana-Farber Cancer Institute. Accessed November 29, 2022, from 

3. Gerson Therapy (PDQ®)–patient version. National Cancer Institute. January 7, 2015. Accessed November 29, 2022. 

4. De Santis, Andy. Dispelling the 3 most common cancer and Diet Myths. American Institute for Cancer Research. February 9, 2022. Accessed November 29, 2022. 

5. Intravenous vitamin C (PDQ®)–patient version. National Cancer Institute. June 24, 2022. Accessed November 29, 2022. 

6. Cannabis and cannabinoids (PDQ®)–patient version. National Cancer Institute. October 14, 2022. Accessed November 29, 2022. https://bit.ly/3CpTGeq


Oncology nurses can help their patients navigate misinformation that they may find online. 

Talking With Patients About Potential Cancer Misinformation

A majority of people in the United States (70%) said they want health systems to be more actively involved with their health management activities, according to the 2022 State of the Healthcare Consumer Report from Kaufman Hall.

People are interested in receiving support for healthy eating (41%), paying for exercise equipment or programs (40%), or providing telehealth visits to discuss symptoms (39%). Overall, 34% of those surveyed manage their diet and nutrition (34%), wear fitness trackers (31%), engage in physical health activities (29%), receive mental health services (22%), practice self-care activities (18%), use at-home diagnostics (12%), and use alternative therapies (12%).

The health management activities that consumers engage in are not always integrated into a medical visit. While 59% of consumers who use mental health services do so under a physician’s supervision, only 43% of consumers who use a wearable device do so under a doctor’s supervision.

“As people adopt behaviors that make them more mindful of their health and well-being, they are increasingly interested in integrating those activities with their health care experience,” said Dan Clarin, a managing director at Kaufman Hall and the report’s lead author, in a statement. “Unfortunately, the health management activities consumers engage in are often disconnected from their clinical care. By listening to their consumers and integrating their insights, health systems have an opportunity to better meet evolving consumer needs.”

The report notes that the narrowing of access to health care services complicates things. Nearly 4 of every 10 people who receive health insurance through their employer have access to 1 plan (38%), or 2 plans (33%). Fewer insurance choices mean fewer affordable options for consumers and clinicians to design the type of health care experience patients may want, with services covered by the plan.

Those in commercial insurance plans reported participating in 8 health management activities on average, while people with Medicaid reported engaging in 6 health management activities.

“Today’s insured consumers often have fewer options for health plans, which can translate into less choice for the services they are looking for,” Clarin said. “At the same time, persistent health care disparities are posing major public health challenges. Health systems must be able to both elevate the voice of the consumer throughout their organizations and play a leading role of lifting the health of the communities they serve.”

Report authors say the health care industry will be increasingly challenged to identify and meet evolving consumer demands for personalized health management, and that incorporating the voice of the consumer will not be easy or quick. Adopting consumer-centric principles to care delivery, and building respectful, sustainable relationships with the patients they serve, will be imperative for health systems moving forward.

Kaufman Hall surveyed approximately 3500 health care consumers for the report.

Clarin D. 2022 State of the healthcare consumer report: who will help consumers put the pieces together? Kaufman Hall. September 27, 2022. Accessed October 21, 2022. 

Physician involvement can determine how much patients benefit from services provided.

Patients want health systems to be more involved in their health

The FDA has approved updated labeling for capecitabine (Xeloda) tablets, making it the first agent to be granted a labeling update under Project Renewal.

Under the updated label, capecitabine is now approved for the adjuvant treatment of patients with stage III colon cancer as monotherapy or in combination with a chemotherapy regimen. Additionally, the agent is approved for the perioperative treatment of adults with locally advanced rectal cancer as a part of chemoradiotherapy and for patients with unresectable or metastatic colorectal cancer, either as a monotherapy or as a component of a combination chemotherapy regimen. In the breast cancer space, capecitabine is approved for patients with advanced or metastatic breast cancer as a single agent if anthracycline- or taxane-containing chemotherapy is not indicated, as well as in combination with docetaxel following disease progression on anthracycline-containing chemotherapy.

For patients with unresectable or metastatic gastric, esophageal, or gastroesophageal junction (GEJ) cancer capecitabine is now indicated as part of a combination chemotherapy regimen and as a part of a combination regimen for patients with HER2-overexpressing disease who have not received prior treatment for metastatic disease. The agent is also indicated as a component of a combination chemotherapy regimen for the adjuvant treatment of adult patients with pancreatic adenocarcinoma.

The Oncology Center of Excellence initiated Project Renewal with the ultimate aim of updating labeling information for oncology agents, especially those that are older and commonly prescribed, by evaluating relevant scientific evidence from published literature. The program utilizes external oncology experts and early-career scientists to review the existing published literature.

The initiative was conceived to address outdated labeling that exists on many oncology agents and applying new information that comes to light in the post-marketing setting that could potentially warrant labeling changes and indication updates. The key goals of Project Renewal are to: develop repeatable processes, use published data, engage with the oncology community, and foster educational experiences.

The recent labeling update also revised and updated the dosing regimen for multiple indications, including allowing for a reduced starting dose for patients with metastatic breast cancer. Under the revision, severe renal impairment was removed as a contraindication, information on risks from exposure to crushed tablets was added in the warnings and precautions section, and more information was given regarding the relationship between treatment with capecitabine and dihydropyrimidine dehydrogenase deficiency. The FDA also updated and revised clinical pharmacology information, the Patient Counseling Information section, and thePatient Information document.

According to the updated label, capecitabine can be given for the adjuvant treatment of patients with colon cancer as monotherapy at a dose of 1,250 mg/m

 twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles or at a dose of 1000 mg/m

 twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m

. For the perioperative treatment of rectal cancer, the agent should be administered at a dose of 825 mg/m

 twice daily for patients who are being treated with concomitant radiation therapy or without radiation therapy, respectively.

Patients with unresectable or metastatic colorectal cancer can be given capecitabine 1250 mg/m

 for the first 14 days of each 21-day cycle as monotherapy or at a dose of 1000 mg/m

 twice daily for the first 14 days of each 21-day cycle when used in combination with oxaliplatin 130 mg/m

 given on day 1 of each cycle. In pancreatic cancer, the agent can be administered at a dose of 830 mg/m

 twice daily for the first 21 days of each 28-day cycle for a maximum of 6 cycles in combination with gemcitabine 1,000 mg/m

 given on days 1, 8, and 15 of each cycle.

Patients with advanced or metastatic breast cancer can be treated with capecitabine monotherapy at a dose of either 1,000 mg/m

 twice daily orally for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity. The agent can also be administered at either dosing schedule in combination with docetaxel 75 mg/m

 on day 1 of each cycle in this patient population.

Finally, capecitabine is indicated at a dose of 625 mg/m

 twice daily on days 1 to 21 of each 21-day cycle for a maximum of 8 cycles in combination with platinum-containing chemotherapy or at a dose of 850 mg/m

 twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m

 on day 1, for patients with unresectable or metastatic GEJ cancer. Patients with HER2-overexpressing metastatic GEJ cancer can be treated with the agent at a dose of 1000 mg/m

 twice daily for the first 14 days of each 21-day cycle.

FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal. News release. FDA. December 14, 2022. Accessed December 16, 2022. 

Project renewal. Updated February 15, 2022. Accessed December 16, 2022. 

Xeloda. Prescribing information. Genentech; 2022. Accessed December 16, 2022. 

The FDA has approved updated labeling for capecitabine under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs.

Label Update for Capecitabine Expands and Updates Indications

An advanced-practice RN (APRNs) led discharge education and follow-up program reduced the readmission rate for patients with melanoma who were treated with immune checkpoint inhibitor (ICI) therapy. The findings of the program were published in the 

In the pre-initiative setting (n = 32), 11 patients needed to be readmitted because of an ICI-related toxicity. However, post intervention (n = 13), no patients were readmitted because of an ICI-related toxicity.

“Hospital readmissions are negatively associated with health care quality and costs,” Michelle L. Rohlfs, DNP, APRN, FNP-BC, AOCNP, an advanced practice RN at The University of Texas MD Anderson Cancer Center in Houston, wrote in the study. “Because of the nature of the disease and treatments, readmissions are high in patients with cancer, often occurring within the first few weeks of discharge.”

According to Rohlfs, this evidence-based is 1 strategy to reduce unplanned readmissions for patients with immune-mediated treatment toxicities.

The initiative was based out of the Melanoma Medical Oncology department at The University of Texas MD Anderson Cancer Center, where many patients seek treatment for advanced melanoma. According to Rohlfs, many patients will receive ICI therapy, which typically occur in the outpatient setting. If a significant toxicity occurs, then patients will be admitted to the inpatient setting to treatment with high-dose intravenous steroids. To be eligible for discharge, patients need to be able to transition to oral steroids and be able to continue steroid tapering setting. Close monitoring and concise patient education is key throughout this process to safeguard against readmission.

The department had a 30-day readmission rate of 22%, which was above the institutional goal of 10%. Thus, APRNs working in the department developed and implemented a structured patient discharge program to help improve readmission rates for these patients.

A literature review revealed that most hospital readmissions occur within 7 to 10 days of discharge, and that patients who received ICIs are at a greater risk for readmission because of these agents posit a high risk of immune-mediated toxicities. It also showcased that high-quality discharge programs can reduce readmission rates as they improve care transitions, and that nurse-led follow-up telephone call programs have been effective in reducing readmissions.

To that end, APRNs created a teaching program for patients who were admitted to the impatient unit with an immune-mediated toxicity. As per the program, patients received daily education while still in impatient setting regarding their specific toxicity and signs to look out for. Once they were discharged, the APRN followed-up with phone calls on days 3, 6, and 9. Each phone call lasted approximately 30 minutes, and APRNS would use the American Society of Clinical Oncology guidelines to help guide patients thought symptom management over the phone.

The discharge teaching tools included and administration and daily checklist, a day-of-discharge checklist, post-discharge telephone follow-up script.

The administration and daily checklist included the following protocols:

Identify where the patient will return upon discharge.

Instruct the patient or caregiver on the practice of using the whiteboard to write down questions. The care team writes down goals of care.

Distribute special immune-mediated toxicity education to the patient or caregiver (eg, National Comprehensive Cancer Network education).

Give verbal education regarding the patient’s diagnosis.

Identify any homecare needs. Arrangements should be made with the team if needed (eg, physical or occupational therapy, case management, social work).

The day-of-discharge checklist outlined the following protocols:

Distribute the Quality of Discharge Teaching Scale to the patient or caregiver.

Discuss postdischarge follow-up telephone calls.

Medication teaching and reconciliation should be completed the day before or day of discharge.

Review the patient’s condition, including the continuation of care in the outpatient setting and warning signs to monitor after discharge.

If the caregiver is not in the hospital, discuss via telephone and address further questions.

Discuss follow-up appointments with the oncology team and specialty services, if applicable.

If home care is needed, arrange it before the discharge date.

Place all discharge teaching information in the after-visit summary.

Provide contact information for the healthcare team.

Lastly, the post-discharge follow-up script included the following questions:

Do you have any questions regarding your recent hospital stay?

Do you have any questions about how to take your medications?

Do you have any questions about the discharge instructions given to you during the hospitalization?

Do you know when your follow-up visit is with [insert medical oncologist name]?

Were you given a follow-up visit with [insert specialty service]? (if applicable)

Do you have any issues with keeping your follow-up appointments?

Rohlfs noted that the 12-week implementation period was a short period and may not be the breast representative sample. Moreover, the sample size was also small, decreasing the generalization of the findings.

Also, according to the study, APRNs shared that this implementation was time-consuming, as their routine tasks were not decreased. However, as the benefit of the program was clear, study authors suggested timing the calls to occur on days 4 and 10 post discharge and aligning the phone call times to occur during steroid completion.

“This quality improvement initiative illustrates how APRNs can be instrumental in providing high-quality discharge teaching in oncology, which supports institutional and nursing efforts to reduce avoidable readmissions,” Rohlfs concluded.

Rohlfs ML. Decreasing readmission rates in patients with immune-mediated toxicities using an APRN-led discharge teaching program. 

. 2022;26(6):659-663. doi:10.1188/22.CJON.659-663

APRNs developed a discharge program which reduced readmission rates for patients receiving immunotherapy for advanced melanoma. 

APRN-Led Discharge Program Reduces Readmission Rates Following Treatment With Immune Checkpoint Inhibitors 

A cancer diagnosis is difficult to process at any age. But fighting the disease as an adolescent or young adult (AYA) presents unique challenges. 

A patient is considered to be an AYA if diagnosed between the ages of 15 and 39 years.

 In 2022, the number of new AYA cancer diagnoses rose to 87,050, which is 4.5% of new cancer cases at any age, representing a steady increase over the previous 2 decades.

 Some of the most common cancers in this patient population are leukemia and tumors of the brain and other nervous system tumors (ONS), the breast, cervix, and testis.

Although the possibility of death is an important topic to broach with AYA patients, other areas of concern are often overlooked.

 Cancer disrupts the most formative years in the lives of young adults and can impact their emotional, cognitive, and social development.

 It can wreak havoc with their current and future plans, self-image, education, career opportunities, relationships, and ability to have children.

Managing these upheavals is an unmet need for AYA patients, and clinicians can play a key role in helping them navigate the cancer trajectory, including remission and recovery. Body image can influence a person’s self-esteem and interaction with others.

 The physical changes caused by cancer and its treatment can negatively impact the self-image of all patients, but it is largely underemphasized in the AYA population.

 The results of a recent qualitative study showed that 45% of AYAs indicated that treatment-related complications, including alopecia, scarring, and weight gain, were detrimental to their body image and self-esteem.

Sexual dysfunction and concerns about fertility are also felt particularly strongly by AYA patients.

 Not only are they worried about mortality and disease recurrence, but many of the treatments they receive can lead to sterility. Patients whose reproductive organs are removed, who receive metal-based chemotherapy regimens, or who undergo radiation are at high risk of posttreatment infertility. But they do not have to be. Cryopreservation allows for pretreatment harvesting of eggs and sperm. Clinicians should recognize how a cancer diagnosis may impact an AYA’s family planning and initiate candid conversations about their options to help them have a family of their own when they’re ready. 

AYAs diagnosed with cancer also require financial counseling because they experience financial toxicity more than any other age group.

 Compared with older patients, many AYAs are underinsured and often receive their diagnosis just as they are transitioning to financial independence. In addition, they are usually unable to tap into the resources—such as retirement funds or home equity—that older individuals may be able to access.

 Although more than half of AYAs have reported that they would benefit from financial counseling and assistance, almost none receive it unless they know to ask for the specific resources dedicated to helping them.

Finally, learning that treatment is working does not lessen the potential for post-treatment challenges.

 AYA cancer survivors are at an increased risk of developing secondary malignant neoplasms (SMNs), most commonly breast, gastrointestinal, genital, and skin cancer.

 Additional challenges for AYAs include continuing school after treatment or reentering the workforce or the dating pool.

This can be an exceptionally lonely time for AYAs, as they may not have a support system that understands what they are going through. Others may feel as if they are expected to simply be happy about having survived, which creates a sense of guilt and anxiety about conflicting thoughts and emotions they may have.

Adolescents and young adults who have cancer also have a negative body image, financial toxicity, and concerns about family planning.

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