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Patients with ductal carcinoma in situ (DCIS) who received an MRI added to mammography before or immediately after receiving a lumpectomy did not experience an improvement in the rate of disease recurrence, according to the results of a large, retrospective study (J Clin Oncol. 2013; [suppl 26; abstr 57]).
Although no published clinical guidelines currently exist for the use of MRI in patients with newly diagnosed breast cancer, the screening is often ordered to determine whether a clinician missed any areas of cancer or to determine if there was a discrepancy between a mammogram and a physical exam.
“Theoretically, treating this additional disease found by MRI could result in lower rates of local recurrence or contralateral breast cancer down the road,” said Melissa L. Pilewskie, MD, a breast surgeon at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City, and first author of the study.
Since no formal guidelines exist, the use of MRI in newly diagnosed patients varies widely among doctors and hospitals, although a recent survey of US surgeons found that 37% of them routinely use MRI for patients with DCIS. Pilewskie and colleagues hypothesized that this test may be unnecessary since studies have not shown decreased rates of re-excision, with some studies even reporting unnecessary increases in mastectomy rates.
In this study, researchers looked at locoregional recurrence (LRR) rates in women with DCIS and compared the rates in patients who received a perioperative MRI with those who did not. A prospectively maintained database at MSKCC included data on all women who underwent breast-conserving surgery for DCIS between 1997 and 2010, and identified 2321 cases for inclusion in the study. Of those cases, 596 received MRI and 1725 did not.
At a median follow-up of 57 months, there were 184 instances of ipsilateral breast tumor recurrence. The 5-year LRR rates were 8.5% in patients who received MRI and 7.2% in patients who did not, and this difference was not statistically significant (P = .52). At 8 years, LRR rates were 14.6% and 10.2%, respectively. When adjusting for age, menopausal status, family history, presentation, adjuvant ther-apy, margin status, number of excisions, and year of surgery, the researchers did not find that MRI was associated with lower LRR rates. This was also true for patients who received radiation therapy.
Additionally, the researchers looked at contralateral breast cancer event-free rates. At 5 years, both groups had the same event-free rates of 3.5%, and at 8 years, the rate in the group that received MRI was 3.5% compared with 5.1% in patients who did not receive MRI (P = .858).
In the entire cohort, patients who received an MRI did not experience a lower rate of events, whereas patients who received endocrine therapy and had a negative margin status did see improvements in their LRRs, which Pilewskie said was to be expected.
“We did not find an association between perioperative breast MRI and decreased rates of either locoregional recurrence or contralateral breast cancer,” Pilewskie said. “In the absence of evidence that MRI is improving our surgical management or, as we show here, long-term outcomes, the routine use of this test for DCIS should be questioned.”
Presently, guidelines for the use of breast MRI in the perioperative setting for treatment of DCIS are lacking. In this retrospective cohort study conducted by Melissa Pilewskie, MD, at Memorial Sloan-Kettering Cancer Center, perioperative breast MRI with DCIS did not reduce the rate of locoregional recurrence of breast cancer. Certainly, practical application of the use of breast MRI in this setting should be reconsidered.
Breast MRI can be a costly, difficult procedure for some patients and often results in an associated higher mastectomy rate. Some researchers hypothesize that the use of known, effective treatments for DCIS (radiation therapy, systemic endocrine therapy, and adequate surgical margin status) are effective at eradicating occult disease and that perioperative breast MRI does not contribute additional advantages to treatment.
The outcomes of this retrospective study are hypothesis-provoking, and additional randomized trials are needed to investigate whether breast MRI has a role in the management of DCIS.
The addition of albumin-bound paclitaxel (nab-paclitaxel) to the treatment standard gemcitabine significantly lengthened survival in patients with metastatic pancreatic cancer, researchers report (N Engl J Med. 2013;369:1691- 1703).
The results are from the phase III Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT), which found that nab-paclitaxel added to gemcitabine significantly improved overall survival (OS), the primary efficacy endpoint, as well as the secondary endpoints of progression-free survival (PFS) and response rate.
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%.
“This large, randomized, international phase III study showed that nab-paclitaxel plus gemcitabine led to a significant improvement in survival at all time points,” Daniel D. Von Hoff, MD, distinguished professor and physician-in-chief at the Virginia G. Piper Cancer Center at Scottsdale Healthcare/Translational Genomics Research Institute, and colleagues write.
The team randomized 861 patients to receive nab-paclitaxel 125 mg/m2 plus gemcitabine 1000 mg/m2 days 1, 8, and 15 every 4 weeks or gemcitabine alone 1000 mg/m2 weekly for 7 weeks, and afterwards on days 1, 8, and 15 every 4 weeks in the first-line setting. Study participants had a Karnofsky performance-status score ≥70 and had not previously received chemotherapy for metastatic disease.
On the basis of the trial’s results, the FDA recently approved the nab-paclitaxel/gemcitabine combination for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.
Pancreatic cancer is the fourth leading cause of cancer-related mortality in Europe and the United States, the authors pointed out. Gemcitabine has long been the standard first-line treatment for patients with unresectable locally advanced or metastatic pancreatic cancer. The 5-year survival rate in patients with metastatic disease is 2%. Patients receiving gemcitabine have been found to have 1-year survival rates of 17% to 23%.
The present study was prompted by findings from a phase I-II trial of nab-paclitaxel combined with gemcitabine that demonstrated promising efficacy and a manageable safety profile in previously untreated patients with metastatic pancreatic adenocarcinoma.
In the present study, the median OS was 8.5 months for the nab-paclitaxel-gemcitabine group and 6.7 months for the gemcitabine monotherapy. The 1-year survival rates were 35% and 22% in the two groups, respectively, whereas the 2-year survival rates were 9% and 4%.
The nab-paclitaxel-gemcitabine cohort had a median PFS of 5.5 months versus 3.7 months for the gemcitabine monotherapy cohort. The response rate determined by independent review was significantly higher with nab-paclitaxel plus gemcitabine than with solo gemcitabine.
Combination therapy was superior for most prespecified subgroups.
The median duration of treatment was 3.9 months for combination therapy and 2.8 months for treatment with gemcitabine alone.
The overall safety profile for the two treatment regimens was in line with that cited in earlier reports. The rate of serious life-threatening events was similar with the two regimens, and adverse events were usually grade 3 or lower and resolved without specific treatment.
Peripheral neuropathy, however, occurred more often in patients who received combination therapy but generally rapidly resolved when nab-paclitaxel was withdrawn temporarily after which the dosage was decreased and treatment resumed.
The investigators point out that the study was conducted at academic and community centers in North America, Europe, and Australia. Additional strengths included the use of randomization and the large sample, which produced similar treatment groups.
They added that a shortcoming of their study was that they did not measure quality of life.
The results of the MPACT study are very exciting to any oncology nurse. Those of us of a certain age remember when essentially all we had to offer was fluorouracil (5FU) or palliative care.
Gemcitabine was approved in 1996 as first-line treatment for patients with locally advanced or metastatic adenocarcinoma of the pancreas for patients previously treated with 5FU. Gemcitabine not only increased overall survival (OS) but improved quality of life, and became the gold standard for treating adenocarcinoma of the pancreas. Over the years it was used in various combinations, ie, GTX (gemcitabine/docetaxel/ capecitabine).
In 2004, a retrospective study looked at GTX and determined it demonstrated excellent response rates and superior survival; however, no phase III studies were done comparing it with gemcitabine alone. Gemcitabine was also used in combination with oxaliplatin (gem/ox); however, this never became a standard of care.
In 2010 the PRODIGE 4/ACCORD 11 trial found the FOLFIRINOX (fluorouracil/leucovorin/irinotecan/ oxaliplatin) regimen doubled median progression-free survival and improved median overall survival from 6.8 months to 11.1 months when compared to gemcitabine in patients with metastatic adenocarcinoma of the pancreas. This essentially revolutionized the treatment of metastatic pancreatic cancer. The downside is that this is a very difficult regimen for patients to tolerate. It requires growth factor support, aggressive antiemetics, and, frequently, visits to our center for intravenous fluids due to dehydration either from inadequate intake or diarrhea. In addition, those patients who are elderly and/or with many comorbidities might not be good candidates for such an aggressive therapy.
Now in 2013 comes MPACT which showed that the addition of nab-paclitaxel to gemcitabine significantly improved OS, as well as progression-free survival (PFS) and response rate compared with gemcitabine alone. This led to its approval for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas. Unbelievably, we now have another weapon in our arsenal. This regimen would certainly be appropriate for many of the patients who either are not be able to tolerate FOLFIRINOX, or even for those patients who progress on FOLFIRINOX, and would certainly offer a better outcome than gemcitabine alone. While outcomes are still not what we would like to see, we certainly are able to offer patients better outcomes than we could even 5 years ago. Hopefully, this trend will continue.
Head and neck cancer patients who participated in a swallow preservation protocol (SPP) were less likely to suffer from the detrimental effects associated with dysphagia, a common complication associated with radiation therapy (RT) and chemoradiation therapy (CRT), according to a new study.
Traditional treatments for head and neck cancers involve surgery and RT, but with newer, more targeted chemotherapy options available, many cancer types can be treated with CRT. Because CRT is often more targeted, it is hoped that more tissue and structure can be spared from damage. Unfortunately, preservation does not always translate to normal, natural swallowing ability.
Dysphagia is a main predictor of poor posttreatment quality of life in patients with head and neck cancer, and current clinical interventions to address this symptom in patients undergoing RT and CRT are limited; those that are currently available follow a therapeutic or rehabilitative model rather than a preventive one.
During early radiation treatment, side effects such as odynophagia, mucositis, or xerostomia can limit the patient’s desire and ability to swallow, and even brief episodes of oropharyngeal rest or lack of exercise during CRT may be associated with prolonged dysphagia.
Marilene B. Wang, MD, professor-in-residence in the department of Head and Neck Surgery at UCLA’s David Geffen School of Medicine and colleagues, identified 85 patients who underwent RT or CRT at a tertiary care academic medical center from 2007-2012 to participate in the study evaluating whether an SPP implemented before, during, and after RT and CRT could help maintain posttreatment swallow function. Patients were divided into two groups based on self-reported compliance, with compliant defined as performance of at least one full set of exercises per day (n = 57) and noncompliant (n = 28) as performing less than one full set of swallowing exercise per day.
The aim of the program was to maintain range of motion of oral, pharyngeal, and laryngeal structures involved in swallowing and limit the fibrosis associated with radiation that often leads to restricted range of motion resulting in dysphagia, as well as to encourage patients to continue oral intake as much as possible, despite dysgeusia and odynophagia.
As part of the SPP, every patient underwent evaluation by a speech-language pathologist (SLP) prior to treatment. Patient demographic data, primary tumor site, stage of tumor, type of treatment (RT or CRT), radiation dose administered to the primary site, and other relevant information were recorded. Patients completed a form to track the swallowing exercises performed and brought the form to each weekly SPP visit.
Other aspects of the protocol included a pretreatment swallow assessment conducted with patients 2 weeks prior to cancer treatment involving education about their cancer and expected treatment side effects, assessing for pretreatment dysphagia, as well as introducing the exercise program.
Swallowing exercises were reinforced by the SLP with the aim of increasing adherence and assessing performance. The exercises consisted of gargling liquid for 10 seconds 10 times, effortful swallowing 10 times, performing a Mendelsohn maneuver 10 times, chugging 3 ounces at once, tongue protrusion 10 times, tongue press 10 times, and Shaker head lifts 3 times. These sets were performed 3 times daily (3 sets), except for the Shaker exercise, which was performed once per day (1 set).
One month after completion of therapy, 31 of the compliant patients (54.4%) were eating a regular, chewable diet, versus just 6 in the noncompliant cohort (21.4% [P = .008]). In addition, 13 compliant patients were found to be G-tube dependent (22.8%) compared with 53.6% of those who did not perform the exercises consistently (P = .008).
The real benefit of complying with swallow exercises before and during RT and CRT, noted researchers, is that the swallowing function is better preserved at the conclusion of therapy and thus patients benefit immediately from improvement or maintenance of swallowing as they do not have to wait 3 to 12 months after therapy for swallowing potential to return.
The authors concluded that compliance with an SPP leads to a faster return to normal diet and prevention of future esophageal stenosis. Larger and longer-term, prospective, randomized studies are needed for assessment of the relationship between swallow preservation therapy and changes in quality of life.
“Our results demonstrate that compliance with swallow therapy during radiation or chemoradiation treatment is beneficial to patients’ retaining their ability to swallow after treatment is over,” said Wang. “The real benefit of this compliance is that patients benefit immediately after treatment, and for a prolonged time afterward. Attending our weekly program, fully committing to the exercises, and being monitored by our staff appears to have a significantly measurable effect on these patients.”
The study was published online ahead of print in the journal Otolaryngology—Head and Neck Surgery on August 27, 2013.
Patients with head and neck cancer have a unique set of sequela that begins prior to treatment and persists or worsens during treatment and after. This is especially true of dysphagia. In this study, Wang, et al, aimed to decrease the effects of dysphagia with the use of swallowing exercises prior to and throughout treatment. The results, as anticipated, showed that those patients who completed their exercises as prescribed had better outcomes than those who did not follow through. The authors pointed out that specialized assessments and education are needed in order for patients to reach the best outcomes. Successful treatment of patients with head and neck cancer is an excellent example of the need for multidisciplinary care.
In this study, the speech-language pathologist (SLP) and physician assessed the patients for swallowing difficulties and provided exercises designed to improve their swallowing ability. Where I believe the study could be even stronger is to involve the nurse in the process. The physician and SLP only saw the patient at certain intervals to assess compliance as well as outcomes. It was pointed out that there were a variety of reasons for noncompliance as well as dropout rates. However, if the nurse— who sees the patient on a much more frequent basis—were involved, perhaps compliance would have been higher with even better outcomes.
It is important that nurses are familiar with the phases of swallowing as well as indications of swallowing difficulties. Swallowing occurs in four phases. In the oral preparatory phase, food is ground and manipulated in the mouth to form a bolus appropriate for safe swallowing. The oral phase is initiated when the tongue presses the food bolus against the hard palate while the soft palate rises and the bolus moves backwards to the tonsillar pillars. In the pharyngeal phase, the food is propelled posteriorly while the larynx closes to the level of the vocal chords, the epiglottis covers the laryngeal vestibule, and the pharynx constricts. Finally, in the esophageal phase, peristaltic contractions of the muscles result in the bolus moving into the stomach. The entire process takes less than 10 seconds.
It is clear that a myriad of structures need to be intact and working together for adequate swallowing to occur. The nurse should be aware of triggers that may indicate an abnormality in one or more of these phases. Such triggers include the inability to control food, liquids, or saliva in the mouth pocketing of food in the cheek, excessive chewing, drooling, coughing, choking or throat clearing before, during, or after swallowing, abnormal voice quality after swallowing, “wet” or “gurgly” voice, congestion following a meal, complaints of food “sticking” in the throat, nasal regurgitation and weight loss.1,2
As this study pointed out, early interventions for swallowing difficulties were effective in returning the patient to a normal diet as well as decreasing the need for feeding tubes. The nurse is in the ideal position to assess the patient on an ongoing, frequent basis and refer to the proper healthcare provider for follow-up. When the physician, SLP, nurse, dietician, physical therapist, radiation therapist, and other caregivers involved in the patient’s care all work together, the outcomes can only be better. I think it would be an interesting adjunct to this study to repeat it with nurses involved in more frequent assessment to see if early detection of problems with proper consults for intervention would increase the compliance of patients. Who knows, you may see that coming soon.
Men who experience hot flashes because they are undergoing androgendeprivation therapy for prostate cancer are not significantly helped by two treatments that alleviate the same symptom in menopausal women, the results of a study show.1
The study, which tested soy protein powder and the antidepressant venlafaxine as therapies for hot flashes in men, was stopped early by a Data Safety Monitoring Board for lack of effect, Vitolins et al reported.
The authors said they conducted the research because, while 80% of androgen-deprived men experience hot flashes that negatively affect their quality of life, there have been few intervention studies aimed at relieving the symptom in men.
“Changing hormone levels cause hot flashes in both women and men, so we hoped that using soy supplements and/or an antidepressant would help reduce them in men as it does in many women,” said Mara Vitolins, DrPH, professor of Public Health Sciences at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina, and lead author of the study, which was published in the September 30 online issue of the Journal of Clinical Oncology.
The authors chose to test venlafaxine based on the results of previous studies. They cited a single-arm pilot study of 16 men by Quella et al,2 who reported that venlafaxine given at 12.5 mg twice a day reduced the severity of hot flashes by ≥50% in more than half of participants. But in a separate 12-week, double-blind trial of 301 men taking leuprorelin,3 the authors recalled, Irani et al found that venlafaxine given at 75 mg a day was less effective than medroxyprogesterone acetate or cyproterone acetate in reducing hot flashes.
The rationale for including soy protein in the study was prior evidence that women living in countries where soy is routinely consumed have fewer menopausal symptoms. Isoflavones, plant substances in soy protein, are weak estrogen agonists, Vitolins and colleagues noted.
“Because venlafaxine and soy have an impact on different physiologic mechanisms proposed to play a role in hot flashes, these treatments could potentially provide more relief when taken together,” the authors hypothesized.
The phase III, double-blind, multicenter study included 120 androgen-deprived men between 46 and 91 years of age, most of them Caucasian and obese. The men had a performance status of 0 to 1, were experiencing ≥4 moderate to severe hot flashes per day, and were expected to live ≥9 months.
The men were assigned for 12 weeks to one of four daily regimens: milk protein powder plus placebo; venlafaxine and milk protein powder; soy protein powder and placebo; or venlafaxine and soy protein powder.
The primary endpoint was hot flash symptom severity score (HFSSS), defined as number of hot flashes times severity. The secondary endpoint was quality of life (QOL), assessed via the Functional Assessment of Cancer Therapy-Prostate.
The investigators found no significant effect on HFSSS due to the use of venlafaxine or soy protein, either as monotherapies or in combination. While participants taking venlafaxine experienced a decrease in hot flash occurrences and severity at the outset of the study, that advantage disappeared after 4 weeks, the authors wrote. Soy protein alone improved measures of QOL in the men. The toxicity of the agents used in the study was minimal, the authors reported.
“Utilizing interventions that appear effective in decreasing hot flashes in women to treat men who have hot flashes has proven to be relatively ineffective,” Vitolins concluded.
These findings highlight the need for continuing efforts to identify treatments for hot flashes that are specifically developed for men, she said. The authors also speculated that venlafaxine may more effectively eradicate hot flashes in this population of men at a lower dose, similar to the one used in the Quella study.
As nurses, we embrace our role in symptom management and its impact upon our patients’ quality of life. Major symptoms, such as pain and nausea, have relatively large numbers of studies contributing to evidence-based practice.
Symptoms that could be called minor, however, including hot flashes, do not have yet a large database of evidence-based practice. Still these can have potentially major effects on a patient’s cancer care and quality of life.
Although, at a glance, this study’s findings are not encouraging, they are an important contribution to the evidence in hot flash symptom management, demonstrating a potential difference in response based upon gender. Much of the evidence to date has focused upon breast cancer patients undergoing hormonal therapies, revealing some insights into the mechanism of hot flashes, as well as the role of venlafaxine and soy in alleviating symptoms.
An important component of building evidence-based practice in symptom management is identifying the interventions that do not work. For our prostate cancer patients on androgen deprivation therapy (ADT), perhaps we may be less likely to include venlafaxine or soy in our symptom management toolbox as first choices (one study is not enough for us to eliminate these options altogether yet).
In prostate cancer, ADT can be a crucial component in treatment or palliation, but side effects such as hot flashes can greatly reduce a patient’s tolerance of ADT, even to the point where patients opt out of the treatment. Future studies still need to be conducted that focus upon men with prostate cancer on ADT, so we can best adjust our symptom management toolbox. By minimizing the impact of treatment-related symptoms such as hot flashes, our patients dealing with prostate cancer can be encouraged to continue ADT, leading to optimal treatment regimens and overall outcomes.