“A new Yale study suggests that patients with a common form of lung cancer may still benefit from delayed chemotherapy started up to four months after surgery, according to the researchers.
“The study was published online by JAMA Oncology on Jan. 5, 2017.
“Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. For patients with non-small-cell lung cancer (NSCLC) — one of two major types of lung cancer — chemotherapy after cancer surgery has been shown to benefit patients with larger tumors or those with cancer in the lymph nodes.”
“A new drug application (NDA) for neratinib as an extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin) has been accepted by the FDA, according to a statement from the developer of the TKI, Puma Biotechnology.
“The application included findings from the phase III ExteNET study, in which neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, according to findings published in Lancet Oncology. The FDA completes a standard review within 12 months from the time of submission, which was completed for neratinib on July 21, 2016.”
“A prospective study of guideline-based, postoperative, image-guided intensity-modulated radiation therapy in patients with prostate cancer found low toxicity profiles and favorable patient-reported quality of life following treatment, with researchers concluding that toxicity and health-related quality of life should not impact the recommendation of radiation therapy following prostatectomy. The research was published by Berlin et al in Practical Radiation Oncology.
“Postprostatectomy radiation therapy has been reported as underutilized, with randomized trials showing the benefit of adjuvant radiation therapy, but only about 10% of patients receiving the treatment. One potential reason for underutilization could be concern over side effects or a negative impact on health-related quality of life.”
“Postsurgical chemo-immunotherapy offers improved survival rates for patients with non–small-cell lung cancer (NSCLC), compared to adjuvant chemotherapy alone, according to the final analysis and long-term results from a small randomized, controlled phase III study in Japan. The findings were presented at the 2015 World Conference on Lung Cancer in Denver, Colorado (abstract 04.01).
“Immunotherapy in the trial consisted of adoptive transfer of autologous activated killer T cells and dendritic cells from patients’ regional lymph nodes, explained lead study author Hideki Kimura, MD, PhD, of Saiseikai Narashino Hospital in Narashino City, Japan.
“ ‘The final results of the statistical and immunological analysis of the study confirmed the efficacy of immunotherapy in adjuvant treatment of lung cancer patients,’ reported Dr. Kimura. A large-scale multi-institutional randomized controlled trial is needed and ‘inevitable’ for the study’s findings to see clinical application, he said.”
“Results of an EORTC trial appearing in The Lancet Oncology show that adjuvant Ipilimumab significantly improves recurrence-free survival in patients with completely resected stage III melanoma at high risk of disease recurrence, but that this treatment was also associated with a high rate of immune-related adverse events.
“Prof Alexander M M Eggermont of the Gustave Roussy Cancer Campus and lead author of this study says, ‘Ipilimumab has already been approved as a treatment for patients with advanced melanoma. Our intention with this study was to assess Ipilimumab as an adjuvant treatment for patients with completely resected stage III melanoma at high risk of recurrence. In my experience, this marks both the first clinical trial of an approved drug with an effect on survival in advanced melanoma in the adjuvant setting, and, in this same setting, the first to study an immune checkpoint inhibitor in the adjuvant setting. Our results show that Ipilimumab is active in the adjuvant setting, but the side-effects are considerable.’
“Between 2008 and 2011, the double-blind, phase III EORTC trial 18071 accrued 951 patients who were randomly assigned to receive either Ipilimumab (475 patients) or placebo (476 patients). All patients were included in the intention-to-treat analyses. At a median follow-up of 2.74 years, the median recurrence-free survival was 26.1 months (95% confidence interval (CI) 19.3 – 39.3) in the Ipilimumab group and 17.1 months (95% CI 13.4 – 21.6) in the placebo group (hazard ratio 0.75; 95% CI 0.64 – 0.90; p = 0.0013). The 3-year recurrence-free survival rate was 46.5% (95% CI 41.5 – 51.3) in the Ipilimumab group and 34.8% (30.1 – 39.5) in the placebo group.”
“Despite strong evidence and guidelines supporting its use, post-surgical radiation therapy for prostate cancer patients at risk of recurrence is declining in the United States. The study, published online in the journal European Urology, finds fewer than 10 percent of patients at risk of recurrence received postoperative radiotherapy within six months of surgery in the U.S.
“Although radical prostatectomy (RP) is a common curative treatment for localized prostate cancer, about 30% of patients will develop biochemical recurrence after surgery, meaning their prostate-specific antigen (PSA) level will again rise. For some patients with more aggressive cancers, as many as 60% to 70% can experience biochemical recurrence (also called biochemical failure).
“Three large randomized prospective clinical trials, two done in Europe and one in the United States, have demonstrated that postoperative radiotherapy (RT) in patients with adverse pathological features reduces risk of PSA recurrence, may prevent the need for androgen deprivation therapy (ADT), and may reduce metastasis and improve survival.”
The gist: New research shows interesting results for a test that’s used to determine whether early-stage breast cancer patients need chemotherapy after tumor-removal surgery. The test, called Oncotype DX, is linked with lower chemotherapy use in younger patients, but not in patients 66 years old or older. The test is used for patients with lymph node-negative, hormone receptor (HR)-positive and HER2-negative breast cancer. It looks at a patient’s tumor genes to determine how likely a return of cancer later on (recurrence) might be.
“In what’s believed to be one of the largest population-based studies of Oncotype DX ever conducted, researchers at The University of Texas MD Anderson Cancer Center have found that the commercial diagnostic tool, Oncotype DX, was associated with a decrease in chemotherapy use in younger patients, but not in those over 66 years of age.
“Mariana Chavez Mac Gregor, M.D., assistant professor, health services research and breast medical oncology, will present the findings at a poster session of the 2014 San Antonio Breast Cancer Symposium.
“Oncotype DX is a 21-gene assay used to help estimate the likelihood of recurrence in women with early-stage breast cancer and, thus, determine those who may or may not benefit from adjuvant chemotherapy. The National Comprehensive Cancer Network includes its use for women with lymph node-negative, hormone receptor (HR)-positive and HER2-negative disease…
” ‘In the younger group of breast cancer patients for whom the test is appropriate, and when used in this setting, we’re finding an important reduction in chemotherapy use. The contrast between older and younger patients’ results did surprise us. However, generally, older breast cancer patients receive much less chemotherapy because of their age and because they often have additional co-morbidities. Perhaps we will see that impact with time,’ said Chavez Mac Gregor.”
The gist: Doctors can sometimes make more personalized treatment decisions based on distinct genetic characteristics of a patient’s tumor. A recent study found that tumor genetics could help prostate cancer patients decide what treatment(s) to take after radical prostatectomy. Specifically, it could help determine which patients might benefit from post-surgery radiation treatment. This could also help patients who don’t need radiation avoid its potentially serious side effects.
“A genomic classifier may be effective in predicting the risk of biochemical failure and distant metastasis in post-surgery radiation in patients with prostate cancer who have undergone radical prostatectomy, according to recent findings.
“These findings suggest utility for a genomic classifier in deciding a patient’s course of treatment after radical prostatectomy, particularly in terms of identifying which patients will benefit from additional radiation.
“ ‘We are moving away from treating everyone the same,’ researcher Robert Den, MD, assistant professor of radiation oncology and cancer biology at Thomas Jefferson University in Philadelphia, said in a press release. ‘Genomic tools are letting us gauge which cancers are more aggressive and should be treated earlier with radiation, and which ones are unlikely to benefit from additional therapy.’ ”