Clinical Insights: October 2013


CE lesson worth 1.0 contact hour that is intended for advanced practice nurses, registered nurses, and other healthcare professionals who care for cancer patients.


The overall goal is to update the healthcare professional’s knowledge of cancer detection and prevention and to understand current and new research regarding state-of-the-art care for those with or at risk for cancer.


Intended for advanced practice nurses, registered nurses, and other healthcare professionals who care for cancer patients.


Upon completion, participants should be able to:

  • Describe new preventive options and treatments for cancer patients
  • Identify options for individualizing the treatment for cancer patients
  • Review new evidence to facilitate survivorship and supportive care for cancer patients



Dannemiller is approved by the California Board of Registered Nursing, Provider Number 4229, for 1.0 contact hours. CBRN credit is not accepted by the Michigan and Utah State licensing boards.


Dannemiller is approved as a provider of nurse practitioner continuing education by the American Association of Nurse Practitioners: AANP Provider Number 090419. The program was planned in accordance with AANP CE Standards and Policies and AANP Commercial Support Standards. It provides 1.0 contact hours of continuing education (which includes 0.0 hours of pharmacology).


The planners and authors of this CE activity have disclosed no relevant financial relationships with any commercial companies pertaining to this activity.


To resolve identified/potential conflicts of interest, the educational content was fully reviewed by a member of the Dannemiller Clinical Content Review Committee, Gloria Herrera, RN, MSN, FNP-BC, who has no financial relationships with commercial interests. The resulting certified activity was found to provide educational content that is current, evidence based and commercially balanced. *Note: Please list the reviewer(s) name and disclosure provided by Dannemiller (physician, RD, and/or NP)


The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of Dannemiller or OncLive. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.


This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by FDA. The faculty have been asked to disclose this information when presented. The opinions expressed in the educational activity are those of the faculty. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. Further, participants should appraise the information presented critically and are encouraged to consult appropriate resources for any product or device mentioned in this activity.


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Breast Cancer

Radiation Therapy for DCIS Does Not Increase Risk of Cardiovascular Disease

Women with ductal carcinoma in situ (DCIS) treated with radiation therapy had no increased risk of cardiovascular disease (CVD) compared with women in the general population or women with DCIS treated with surgery, according to results of a study in The Netherlands. The study was presented at the 2013 Breast Cancer Symposium, held September 7-9, 2013 in San Francisco, California. Abstract 58

“Doctors have been worried about late effects of breast radiation therapy, particularly cardiovascular disease,” said Naomi B. Boekel, MSc, the study’s lead author and a PhD student at The Netherlands Cancer Institute in Amsterdam. “Our findings suggest that routine radiation therapy for women with DCIS does not appear to increase the risk of developing cardiovascular disease later in life.”

The researchers collected data on 10,468 women in The Netherlands diagnosed with DCIS before age 75 years between 1989 and 2004. About 71% of the women were treated with surgery alone (43% had a mastectomy and the rest underwent lumpectomy) and 28% were treated with surgery and radiotherapy. The median follow-up was 10 years; 19% of the women were followed for 15 years or more. The study compared the risk of CVD in women treated with radiotherapy with that of the general population of Dutch women and to different treatment groups of women with DCIS.

Compared with the general population, women with DCIS had a similar risk of dying from any cause and a 30% lower risk of dying of CVD. No difference was found in the risk of CVD in women treated with radiotherapy versus surgery alone (8% of patients treated with surgery plus radiation were diagnosed with CVD vs 9% treated with surgery alone). Likewise, no significant differences in the risk of CVD were observed in patients who received left-side radiotherapy (7%) versus right-side (8%).

The findings are important in light of current concerns about overtreating patients with DCIS, said Boekel. Radiation therapy following lumpectomy for DCIS approximately halves the rate of cancer recurrence in the same breast. However, previous studies in breast and other cancers have shown that radiation to the heart region can increase the long-term risk of CVD, and in recent years, radiation therapy protocols have been adjusted to decrease exposure of the heart to radiation.

The slightly lower risk of dying from CVD in women with DCIS might be the result of those women being more health conscious than the general population, so that they underwent breast cancer screening or adopted a healthier lifestyle after DCIS diagnosis, Boekel said. In addition, factors such as education, socioeconomic status, and conflicting risk factors between CVD and DCIS (eg, age at menopause) may also play a role. “Studies with longer follow-up after breast radiation therapy are needed before definitive conclusions about cardiovascular disease risk can be drawn,” she said.

T-DM1 in Previously Treated HER2+ Metastatic Breast Cancer

An analysis of the T-PAS expanded access study of trastuzumab emtansine (T-DM1) in previously treated HER2+ metastatic breast cancer (MBC) confirmed existing information on the safety of the combination, and observed significant clinical activity in a patient population that averaged seven prior therapies. The analysis was presented at the 2013 Breast Cancer Symposium, held September 7-9 in San Francisco, California. Abstract 166

The study enrolled 215 HER2+ (IHC 3+ or FISH/CISH+) patients with locally advanced or MBC and left ventricular ejection fraction (LVEF) ≥50%. All of the patients, who received 3.6 mg/kg of T-DM1 every 3 weeks, had already been treated with an anthracycline and a taxane as well as capecitabine or 5-FU and ≥2 HER2-directed agents (including trastuzumab and lapatinib).

At baseline, the median LVEF was 60%, and 50% of patients had investigator-reported cardiovascular disease. The median follow-up was 5.9 months; median T-DM1 duration was 5.0 months, with 15.8% receiving >18 cycles. Objective response rate, as assessed by investigators on day 1 of every cycle, was 25.6%.

The rate of ≥grade 3 adverse events was 43.7%, and rate of serious adverse events of any grade was 18.1%. The most common ≥ grade 3 adverse events were thrombocytopenia (7.9%), fatigue (4.7%), and increased aspartate aminotransferase and anemia (3.7%). Cardiac dysfunction (primarily asymptomatic decreases in LVEF) of any grade occurred in eight patients and of ≥ grade 3 in four patients. There were no ≥ grade 3 bleeding events.

Breast Cancer Patients Prefer Subcutaneous Trastuzumab

Women with HER2-positive early breast cancer favor subcutaneous over intravenous (IV) administration of trastuzumab (Herceptin), according to the results of the PrefHer study (Lancet Oncol. 2013;14[10]:962-970).

Xavier Pivot, MD, with CHU Jean Minjoz in Besançon, France, and coworkers elsewhere randomized subjects to receive four cycles of 600-mg fixed-dose subcutaneous adjuvant trastuzumab administered via a single-use injection device or handheld syringe, followed by four cycles of IV trastuzumab, or the reverse sequence. Treatment regimens containing IV trastuzumab are the standard of care for patients with HER2-positive breast cancer.

In the 596-patient, phase III HANNAH trial, subcutaneous trastuzumab demonstrated a pharmacokinetic profile and efficacy that was noninferior to IV administration, with a similar safety profile.

The PrefHer study included women with HER2- positive primary invasive breast adenocarcinoma and evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy.

Study participants were either trastuzumabnaïve (de novo group) or had already received IV trastuzumab as part of a concurrent or sequential regimen following neoadjuvant or adjuvant chemotherapy (non-de novo group). The non-de novo patients had to have had at least eight of 18 planned thrice-weekly trastuzumab cycles left to complete prior to enrollment.

The researchers noted that subcutaneous trastuzumab administration has an injection time of less than 5 minutes versus 30 to 90 minutes for IV administration, which is important in longterm or single-agent trastuzumab therapy. Additional advantages include decreased use of both hospital resources and the services of healthcare professionals.

Subcutaneous trastuzumab was recently approved in Europe for the treatment of women with HER2-positive early breast cancer.

The evaluable intent-to-treat population included 117 patients who received subcutaneous trastuzumab followed by IV trastuzumab and 119 patients who received IV trastuzumab followed by subcutaneous trastuzumab.

The two treatment groups were similar with respect to demographics, characteristics, and treatment history. Patient preferences for route of administration were determined by telephone interviews.

Overall, 216 patients (91.5%) said they preferred subcutaneous trastuzumab administration (95%CI, 87.2-94.7, P <.0001), 16 patients (6.8%; 95%CI, 3.9-10.8) favored IV delivery, and 4 patients (1.7%; 95%CI 0.5-4.3) reported no preference.

Further analysis revealed a preference for subcutaneous trastuzumab irrespective of trastuzumab therapy before enrollment (54 of 57 [94.7%, 95%CI, 85.4-98.9] in the de novo group and 162 of 179 [90.5%, 95% CI, 85.2-94.4] in the non-de novo group).

Clinician-reported adverse events occurred in 58% of patients during the pooled subcutaneous periods versus 44% of patients during the pooled IV periods.

However, this pattern was not demonstrated in patient-reported events, in which case decreased pain or discomfort was the second most common reason given for preference of subcutaneous administration.

The main reason that patients cited for preferring the subcutaneous route of administration was that it saved time.

Pivot et al noted that the study’s main strengths “lie with its prospective randomized design and the primary analysis.”

In addition, patients were asked about their preference by an independent interviewer “in a comprehensive, quality-controlled interview process.” This method is better than other popular methods of assessing patient preference, including retrospective assessments, questionnaires completed by the treating institution, and healthcare professional—based preference reporting, they said.

The authors concluded that combined data from the PrefHer and HANNAH studies “suggest that a fixed dose of subcutaneous trastuzumab every 3 weeks is a validated, well-tolerated, and preferred option of patients for the treatment of HER2-positive breast cancer.”

Colorectal Cancer

Colonoscopy Screening at 10-Year Intervals May Prevent 40% of Colorectal Cancers

Forty percent of cases of colorectal cancer (CRC) may be prevented if patients at average risk for the disease undergo a screening colonoscopy every 10 years, according to a prospective analysis of data from the Nurses’ Health Study and the Health Professionals Follow-up Study (N Engl J Med. 2013;369:1095-1105).

Reiko Nishihara, PhD, and colleagues at the Harvard School of Public Health analyzed the association between lower GI endoscopy and the long-term risk of incident CRC in two large US prospective cohorts.

“Our findings support the 10-year examination interval recommended by existing guidelines for persons at average risk who have a negative colonoscopy,” the authors reported.

The Nurses’ Health Study included 121,700 female nurses 30 to 55 years of age at the time of enrollment in 1976; the Health Professionals Follow-up Study included 51,529 male healthcare professionals 40 to 75 years of age at enrollment in 1986. The current analysis involved 88,902 participants from the two long-term studies.

Subjects completed questionnaires every 2 years over 22 years. Specifically, they were asked if they had undergone either sigmoidoscopy or colonoscopy and, if so, the reason for the test. The researchers later decided to also collect detailed information on whether an individual’s prior lower endoscopies were colonoscopies or sigmoidoscopies.

During the study period, there were 1815 cases of CRC and 474 deaths from the disease.

The multivariate hazard ratios (HRs) for CRC among individuals who had undergone endoscopy compared with those who had not undergone endoscopy were 0.57 (95% CI, 0.45-0.72) after removal of adenomatous polyps, 0.60 (95% CI, 0.53-0.68) after negative sigmoidoscopy, and 0.44 (95% CI, 0.38-0.52) after negative colonoscopy.

Negative colonoscopy was associated with a significantly decreased risk of proximal CRC (multivariate HR = 0.73; 95% CI, 0.57-0.92).

Nishihara et al also documented lower mortality from colorectal cancer in participants who had undergone screening sigmoidoscopy (multivariate HR=0.59; 95% CI, 0.45-0.76) and in individuals who had undergone screening colonoscopy (multivariate HR=0.32; 95% CI, 0.24-0.45).

Reduced mortality from proximal colon cancer was seen after screening colonoscopy but not after sigmoidoscopy.

The authors said that their findings are in line with the results of the National Polyp Study, which reported a decreased incidence of CRC among individuals after colonoscopic polypectomy versus population-based estimates of expected rates of CRC after colonoscopic polypectomy.

They also noted that because they gathered information every 2 years over 22 years, they were able to update endoscopy status to accurately determine associations with the subsequent risk of CRC or death.

Detailed information about exposures such as lifestyle factors allowed them to “finely adjust” for possible confounders. The prospective design is also an important study strength because it minimized biases that occur with case-control studies, including recall and selection biases.

They cited the potential for unmeasured confounding as a study limitation, including bias due to the use of pooled data from two separate cohorts.

Survivorship Care

Internet-Based Care Plans Improve Provider—Survivor Communication and Promote Lifestyle Changes

Most cancer survivors using an internet tool to assist them in survivorship care planning found the resource to be both informative and helpful as an incentive to make lifestyle and behavior changes, according to findings of a study by researchers at the Perelman School Medicine at the University of Pennsylvania in Philadelphia (Cancer. 2013; doi: 10.1002/cncr.28286).

For this study, researchers looked at the effectiveness of the LIVESTRONG Care Plan—an online, survivorship care plan (SCP) developed at Penn&mdash;among 8690 survivors who used the tool between May 2010 through January 2013. Breast (45%), hematologic (12%), and gastrointestinal (11%) were the most common tumor types among the cohort. The LIVESTRONG Care Plan is a personalized tool available through Penn Medicine’s OncoLink system, whereby survivors create individualized plans based on answers they provide to a brief questionnaire eliciting demographic information and data about their cancer and the type of treatments they received.

The plans provide information to survivors on such issues as symptoms and treatments for potential late effects (including psychosocial effects), recommendations for cancer screening and promoting a healthy lifestyle, as well as a list of support resources. The researchers reported that 29,000 patients and healthcare providers have used the tool since it launched in 2007.

Of the total study cohort, 298 responded to a 1-month follow-up survey: 93% of respondents reported that the information provided through the care plans was excellent, very good, or good, and 65% said that the information that they received had not previously been provided to them by their healthcare team. Eighty percent shared the SCP or expected to share it with their healthcare providers, and for those who had already done so, 80% indicated that the SCP had resulted in improved communication with their provider.

More than 60% believed that the SCP changed their healthcare participation, and 54% had made or anticipated making lifestyle changes because of the SCP, principally in the areas of dietary modification and increased exercise.

“The one constant in the care of cancer survivors is the survivor him or herself,” said Christine Hill-Kayser, MD, an assistant professor of Radiation Oncology at the University of Pennsylvania’s Abramson Cancer Center and the study’s lead author. “By providing the survivor with the resources to know which tests need to be ordered in the form of a written document, a survivorship care plan enables the survivor to take more control of his or her care, and to participate in minimizing the ‘slip through the cracks’ phenomenon.”

“Our results show that care plans are empowering patients to become more active participants in their own healthcare,” noted Hill-Kayser. “This is an important tool that provides patients with greater education and prompts them to be more proactive about their care and more likely to discuss concerns with their providers.”

Nurse Perspective on Internet-Based Care Plans

Emily Beard, RN, OCN, CBCN

Multidisciplinary Care Coordinator

Oncology Support Services

Northside Hospital Cancer Institute

Atlanta, GA

A young breast cancer patient once contacted me after seeing an oncologist for her posttreatment visit. She had completed chemotherapy, radiation, and multiple surgeries so I was surprised when instead of relief she expressed panic and a desperate question: “Now what?” Anxious about no longer having weekly doctor’s visits, and terrified of recurrence, her lack of confidence represents the paradox of survivorship: glad to have completed treatment for a cancer she initially feared would take her life, while riddled with worries about the future and uncertainty about the role she would play in her care going forward.

As the authors of the study from the University of Pennsylvania clearly recognize, the future of quality survivorship care requires innovation and active coordination between patients and providers. The delivery of healthcare to this already enormous — and growing &mdash; population is undergoing a change as survivorship programs require us to partner with our patients in developing models of shared responsibility, empowerment, and new ways of delivering personalized and disease specific care. Earlier this year the NCCN came out with survivorship guidelines to help clinicians address common quality-of-life topics including pain, fatigue, sleep disorders, “chemo brain,” sexuality, depression, as well as recommendations for infection prevention, physical activity, and diet. The LIVESTRONG Survivorship Care Plan (SCP) is one of many tools that have been developed in the last decade as a response to needs outlined in the 2005 IOM report.

While the sheer number of people who have reportedly used the LIVESTRONG SCP online tool since 2007 is impressive, and the demonstration of increased communication with providers and increased levels of patient participation in care are very encouraging, the relatively small (3.5%) percentage of the total number of users surveyed for this study requires a measure of caution when interpreting the impact of the tool overall. There may be some selection bias in this survey of patients, because they are, by use of the tool, identifying themselves as able to access the Internet, not something the entire oncology survivor population can or would do. In order to move forward with evidence-based survivorship program design, we need to continue looking carefully at care plan interventions and the outcomes they generate. If the goal for SCPs is to assist people with cancer in making the transition from patient to empowered survivor in multiple forms and by various means, then this small study represents a promising beginning.

Head and Neck Cancer

NP Clinic Helps Oropharyngeal Cancer Patients Manage Debilitating Side Effects

The supportive care needs of patients receiving intensive chemoradiotherapy for locally advanced oropharyngeal cancer can be considerable due to the often debilitating side effects of this nonsurgical, organ-preserving approach. A retrospective evaluation of visits to a nurse practitioner (NP)—led symptom management clinic, which was established to address these issues, has found that the visitors to the clinic had fewer hospitalizations and chemotherapy dose reductions and were more likely to complete treatment compared with those who did not have the NP clinic option (Oncol Nurs Forum. 2013. 10.1188/13.ONF.40-06AP).

The study found that pazopanib was noninferior to sunitinib in terms of progression-free survival (hazard ratio [HR] = 1.05; 95% CI, 0.90- 1.22), falling within the predefined noninferiority margin (upper bound of 95% CI, <1.25). The overall survival also was similar (HR = 0.91; 95% CI, 0.76-1.08).

Acting on concerns over grade 3 or 4 toxicities among patients being treated with chemoradiotherapy to the oropharynx, the University of Michigan Cancer Center in 2006 developed a symptom management clinic, staffed by two NPs, one RN, and medical assistants. The clinic protocol includes patient visits scheduled at week 2 of treatment and weekly thereafter until 1-2 weeks after treatment completion, a time when patient symptoms often peak. The most common side effects associated with this complex treatment regimen include mucositis, which can lead to debilitating dehydration, weight loss, nausea, and vomiting.

The focus of each clinic visit is on treatment toxicities and any specific concerns of the patient and family caregiver, including physical, psychosocial, and spiritual needs. Other assessments include weight, activity-level measurements, laboratory studies, and a complete physical examination focused on the area affected by the radiotherapy. Supportive care treatment plans are developed for the patient and significant other, including referrals to dieticians and social workers or for feeding tube placement, as needed.

To evaluate the effectiveness of the NP clinic in reducing these symptoms, researchers reviewed the charts of 50 patients treated at the cancer center from January 2002 to August 2006 prior to the opening of the clinic (Group 1) with those of 51 patients treated after the clinic opened, between September 2006 and June 2010.

All patients were aged 45 to 65 years, had stage III or IV oropharyngeal cancer, and were receiving a 7-week treatment plan comprised of 7 weeks of daily radiation (2 Gy, 5 days weekly) plus weekly administration of carboplatin plus paclitaxel.

The researchers looked at three treatment outcomes: hospitalization for treatment toxicities within 2 weeks after treatment began; a reduction in chemotherapy dose, and successful completion of all seven cycles of planned chemotherapy.

Patients treated after the establishment of the NP-led clinic were found to have significantly lower rates of hospitalization compared with those in Group 1 who didn’t have the clinic option (12% vs 28%, respectively) and chemotherapy dose reductions (6% vs 48%). In addition, 90% of patients treated after the clinic opened completed all 7 cycles of their chemotherapy regimens compared with 46% in Group 1.

Investigators also looked at the occurrence of toxicities over the 7-week treatment period and found that the frequency of nausea and vomiting, mucositis, and pain was lower in the supportive care clinic group; however, dehydration and placement of feeding tubes occurred more frequently in the NP-led clinic group, which the researchers note may be the result of earlier diagnoses of nutrition and hydration problems which resulted in more aggressive follow-up.

Limitations of the study include its retrospective design, which could not control for intervening variables, and the relatively small sample size, according to the authors. Although costs were not directly compared in this study, the researchers suggested that a prospective study would allow for the evaluation of more cost-effectiveness variables, as well as measures of patient satisfaction. Another area of inquiry would be to randomize to weekly versus every-other-week clinic visits.

Nurse Perspective on Manage Debilitating Side Effects in Oropharyngeal Cancer Patients

Colleen M. O’Leary, RN, MSN, AOCNS

Clinical Nurse Specialist

The James Cancer Hospital

The Ohio State University Comprehensive Cancer Center

Columbus, OH

Because of the intensity and mulitmodality of treatment for patients with oropharyngeal cancers, they experience a multitude of toxicities and side effects throughout their treatment trajectory. Effects of surgery, chemotherapy, and radiation for these patients include dysphagia, xerostomia, mucositis, pain, fatigue, sleep disturbance, cognitive dysfunction, malnutrition, and weight loss. All of these conditions, along with the often-felt anxiety and depression that accompanies cancer of the head and neck, can have profound effects on the patient’s quality of life. Understanding patients’ symptom experiences and improving their quality of life requires close monitoring and follow-up of any subtle to obvious changes. The use of a multidisciplinary approach can only benefit the patient and family.

The now familiar 2010 Institutes of Medicine (IOM) report on the future of nursing clearly recommends that nurses should practice to the full extent of their education and training, and that nurses should be full partners with physicians and other healthcare professionals. This nurse practitioner (NP)—run clinic is a prime example of that. This study proves once again that the use of NPs to the full extent of their education can only bring positive outcomes for patients. The ability to use the multidisciplinary team, including dieticians and social workers, at the point of care certainly relieves some of the anxiety faced by patients and families, which can often get lost in the flow of a busy clinic.

Advanced practice nurses have the ability to thoroughly assess their patients’ physical as well as psychosocial needs and employ necessary interventions to meet those needs. The outcomes mentioned in this study prove that patients received improved care as demonstrated by fewer hospitalizations, fewer dose reductions, and higher percentages of completion of regimen.

I would have liked the authors to discuss what specific measures they used to assess their patients’ symptoms. Tools such as the Cancer Needs Questionnaire Short Form-head and neck, the Symptom Severity Scale, and the Hospital Anxiety and Depression Scale, are all valid and reliable tools. Additionally, including assessment of the stress and burden to caregivers and how that was affected could be beneficial.

Prostate Cancer

New Data May Dispel Safety Concerns With Finasteride Use in Prostate Cancer Prevention

The Prostate Cancer Prevention Trial (PCPT), conducted from January 1997 to February 2003, demonstrated that the 5α-reductase inhibitor (5-ARI) finasteride reduced the risk of developing prostate cancer in men being regularly screened for the disease; however, at the time, researchers observed that men receiving the drug were more likely to develop high-grade prostate cancer.

Now, 18 years after the first PCPT patient was randomized, a long-term follow-up has confirmed the preventive benefit of finasteride use. Specifically, the drug—currently used by physicians to treat enlarged prostate and male pattern baldness&mdash;proved to be highly effective in reducing the low-grade cancers associated with the overdetection and overtreatment of the disease. Further, the follow-up study dispelled the safety concerns raised in the initial research. (N Engl J Med. 2013;369[7]:603-610)

When the results of the PCPT trial were first published in 2003, that data showed that finasteride reduced the relative risk of prostate cancer by 24.8%. However, the researchers also observed a relative increase of 26.9% in the rate of high-grade prostate cancers in patients who received finasteride compared with those who received a placebo. This caused concern and debate in the medical community, and in 2011, the FDA added a warning to the label about the increased risk of being diagnosed with high-grade prostate cancer.

Ian M. Thompson, Jr, MD, professor in the Department of Urology and director of the University of Texas Cancer Therapy and Research Center, and his colleagues wanted to determine whether this increased risk of developing high-grade prostate cancer had any effect on long- term survival.

To evaluate the effectiveness of the NP clinic in reducing these symptoms, researchers reviewed the charts of 50 patients treated at the cancer center from January 2002 to August 2006 prior to the opening of the clinic (Group 1) with those of 51 patients treated after the clinic opened, between September 2006 and June 2010.

All patients were aged 45 to 65 years, had stage III or IV oropharyngeal cancer, and were receiving a 7-week treatment plan comprised of 7 weeks of daily radiation (2 Gy, 5 days weekly) plus weekly administration of carboplatin plus paclitaxel.

Thompson et al’s current research provides updated survival data through October 31, 2011.

The researchers found that among the 18,880 eligible men who were randomized in the study, 989 of 9423 patients in the finasteride group (10.5%) were diagnosed with prostate cancer, compared with 1412 of 9457 patients in the placebo group (14.9%; relative risk in the finasteride group = 0.70; 95% CI, 0.65-0.76; P <.001).

Among the patients who were evaluated in the study, 333 patients in the finasteride group (3.5%) developed high-grade cancer, defined as a Gleason score of 7 to 10, compared with 286 patients in the placebo group (3.0%; relative risk = 1.17; 95% CI, 1.00-1.37; P = .05).

Using the Social Security Death Index, the researchers determined that 2538 patients in the finasteride group and 2496 patients in the placebo group had died by October 31, 2011. This translated into 15-year survival rates of 78.0% and 78.2%, respectively. The unadjusted hazard ratio for death in patients who received finasteride was 1.02 (95% CI, 0.97-1.08; P = .46).

Additionally, the 10-year survival rates were 83.0% in the finasteride arm of the study compared with 80.9% in the placebo arm for patients who were diagnosed with low-grade prostate cancer. In the high-grade prostate cancer group, the survival rates were 73.0% and 73.6%, respectively.

“If you look at the number of prostate cancers that are diagnosed annually and multiply that by 30%, that’s the number of cancers we might be able to prevent each year,” Thompson said. “That’s more than 71,000 men. That’s more than 175 jumbo jets full of men who won’t get cancer, who won’t face treatments with side effects like sexual dysfunction. There’s nothing like disease prevention. Nothing comes close.”

Nurse Perspective on Finasteride Use in Prostate Cancer Prevention

Frank delaRama, RN, MSN, AOCNS

Clinical Nurse Specialist Oncology Genomics

Prostate Cancer Nurse Navigator

Palo Alto Medical FoundationPalo Alto, CA

New data from this study seems to reopen the debate on finasteride’s safety in use as chemoprevention. The risk-reducing effects of finasteride were known years ago, but there was a small increase in aggressive tumors found in men who used the drug, so the FDA did not allow it to be labeled for use in lowering prostate cancer risk.

Since 2011, finasteride was actually labeled with a warning of an increased risk for high-grade prostate cancer. Some hypothesized that the drug was just shrinking the prostate, allowing the cancers to be found more easily, as opposed to directly causing the cancers to develop. With almost two decades of follow-up from the earlier study, it was found that men who took the drug were not more likely to die, compared with those not on the drug.

Despite this study, there are no concrete recommendations yet on finasteride and prostate cancer prevention, but it does provoke some thoughts on the potential pros and cons:

  • Men thought to have an increased risk, based upon family history or even ethnicity (African-American men) may be good candidates to try finasteride for prostate cancer prevention.
  • Men with rising PSA but negative biopsies may also benefit from the drug.
  • On the con side, the drug is known to cause hot flashes, fatigue, weakness, decreased libido, and even erectile dysfunction.
  • Even if the drug is eventually offered for chemoprevention, men must think about what may happen while on the drug, prioritizing the potential side effects, as well as the actual benefits.
  • Perhaps the drug will reduce the number of low-risk prostate cancers found, helping to avoid unnecessary treatments.

As usual, new developments in prostate cancer provide some promising ideas, but also raise many more questions that need to be considered by men and their healthcare providers. For our patients inquiring about finasteride for chemoprevention, nurses should help patients (and even fellow providers) identify these pros and cons so we can all make the best healthcare decisions given the information at hand.

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