FDA Accepts Neratinib NDA for HER2-Positive Breast Cancer

Excerpt:

“The FDA has accepted 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), 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.”

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Melanoma: New Drugs and New Challenges (Part 2 of 2)


Editor’s note: This is part 2 of a 2-part post on the latest research in melanoma. To learn about research into drug combinations for melanoma that may work better than single drugs, check out Melanoma: New Drugs and New Challenges (Part 1 of 2).

As always, the more new treatments become available in melanoma, the more new challenges arise. With eight new drugs approved for melanoma in the last five years, oncologists may sometimes face the difficult choice of what drugs to choose for a patient’s first-line treatment. Immune checkpoint drugs sometimes cause serious side effects, but progress is being made on how to treat these and also how to treat patients with pre-existing autoimmune conditions. New approaches are needed in efforts to prevent recurrence of melanomas diagnosed at earlier stages of disease progression. These and other challenges are discussed below. Continue reading…


Adjuvant Chemotherapy Improves Overall Survival in Patients With Stage IB Non-Small Cell Lung Cancer

Excerpt:

“The use of adjuvant chemotherapy in early-stage non-small cell lung cancer (NSCLC) patients improves overall survival (OS) and 5-year OS in patients with tumor sizes ranging from 3 – 7 cm.

“Stage I , the earliest stage at which clinicians diagnose lung cancer, is identified in approximately 16% of all lung cancer cases in the U.S. For early-stage  with medically operable clinical NSCLC, surgery is the treatment of choice. Several studies have found that patients with stage II and III NSCLC that had adjuvant chemotherapy following complete surgical resection lived longer than those that had surgery without chemotherapy. However, in early-stage NSCLC patients there currently is not enough evidence to support the use of chemotherapy following complete resection, even though stage I lung cancer recurs either locally or at distant sites in roughly a third of early-stage patients. Exploratory analysis of the use of adjuvant chemotherapy in early-stage patients showed improved overall survival for patients whose tumors were ? 4 cm. Consequently, a thorough investigation of the clinical benefits and survival of the use of adjuvant chemotherapy in early-stage patients is warranted in order to improve the current treatment recommendations.”

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MammaPrint Genetic Test Can Reduce Use of Post-surgery Chemotherapy Among Early-stage Breast Cancer Patients

Excerpt:

“Among patients with early-stage breast cancer who were considered at high risk for disease recurrence based on clinical and biological criteria, the MammaPrint genetic test identified a large group of patients for whom five-year distant metastasis–free survival was equally good whether or not they received adjuvant chemotherapy (chemotherapy given post-surgery), according to results from the randomized, phase III microarray in node negative disease may avoid chemotherapy (MINDACT) clinical trial to be presented here at the AACR Annual Meeting 2016, April 16-20.”

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Oncotype Dx Gene Test Has a Big Impact on Oncologists' Chemo Recommendations

Excerpt:

“The 21-gene Recurrence Score (RS) assay significantly influenced clinicians’ decisions to recommend breast cancer patients for adjuvant chemotherapy, analysis of a population-based dataset showed.

“Used to predict disease recurrence and benefit of chemotherapy in estrogen receptor-positive, lymph node-negative early-stage breast cancer (EBC), the assay had the strongest association with recommendation for chemotherapy, with an adjusted odds ratio (aOR) of 83 for high assay scores and 12 for intermediate scores, both relative to low scores.

“Test use was significantly associated with younger age, white race, academic centers, private insurance, and pT2/pN0(i+) grade 2 to 3 disease, Peter Kabos, MD, of the University of Denver, Aurora, CO, and colleagues reported online in the Journal of Clinical Oncology.”

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Androgen Suppression Plus RT Improves DFS in Prostate Ca

“Adding 6 months of androgen suppression (AS) to radiation therapy improved biochemical disease-free survival in high-risk localized prostate cancer patients – even at radiation doses of 78 Gy – and it did so with acceptable adverse effects, according to a randomized European Organisation for Research and Treatment of Cancer trial reported in the Journal of Clinical Oncology.

“At 7.2 years’ median follow-up, the study found that combination therapy led to a 5-year biochemical disease-free survival of 82.6% (95% CI 78.4-86.1) versus 69.8% for radiation alone (95% CI 64.9-74.2) – translating to a hazard ratio of 0.52 (95% CI 0.41-0.66, P=0.001, 319 events). Adjuvant AS also improved clinical progression-free survival, for an HR of 0.63 (95% CI 0.48-0.84, P=0.001, 205 events).

“No statistically significant interaction between treatment effect and radiation dose emerged: heterogeneity P=0.79 and P=0.66, for biochemical disease-free survival and progression-free survival, respectively, according to Michel Bolla, MD, of Grenoble University Hospital in France, and colleagues.”


EBCC-10 NEWS: Chemotherapy Every Two Weeks for Premenopausal Breast Cancer Patients Improves Survival and Does Not Increase Risk of Early Menopause

“Amsterdam, The Netherlands: Premenopausal women with breast cancer have a better chance of survival if they are given cycles of adjuvant chemotherapy closer together, every two weeks rather than every three weeks. Furthermore, this regimen, known as “dose-dense” adjuvant chemotherapy, does not seem to be associated with an increased risk of treatment induced early menopause.

“The findings will be presented today (Thursday) at the 10th European Breast Cancer Conference (EBCC-10) and the researchers say they are important for helping younger breast cancer patients and their doctors to make better-informed decisions about the choice of chemotherapy regimens that are given in addition to other treatments such as surgery, hormone therapy and radiotherapy.

“Dr Matteo Lambertini, MD, a medical oncologist at IRCCS AOU San Martino-IST, National Institute for Cancer Research, Genoa, Italy [1], and at the Institut Jules Bordet, Brussels, Belgium, will tell the conference: ‘Our results confirm the superiority of dose-dense chemotherapy as compared to standard interval regimens in premenopausal patients at higher risk of relapse, and its use should be implemented in Europe, as it is in the United States.’ ”


ASCO Recommends Ovarian Suppression for ER-Positive Breast Cancer

“An American Society of Clinical Oncology (ASCO) expert panel issued an updated guideline recommending that higher-risk premenopausal women with estrogen receptor (ER)-positive breast cancer receive ovarian suppression in addition to adjuvant endocrine therapy. Lower-risk patients, however, should not receive ovarian suppression.

“ ‘In the past year, randomized trials with robust methodological designs have analyzed the effect of ovarian suppression among premenopausal women with ER-positive breast cancers treated with tamoxifen,’ wrote the panel, led by ASCO expert Harold J. Burstein, MD, PhD, of Dana-Farber Cancer Institute in Boston. In the past, studies of this therapy have suffered from problems such as selection criteria confounding.

“The guideline update is based on four randomized controlled trials. These include the Eastern Cooperative Oncology Group 3193 (E-3193) trial, the Suppression of Ovarian Function Trial (SOFT), the Tamoxifen and Exemestane Trial (TEXT), and the Austrian Breast Cancer Study Group (ABCSG)-12 trial. Overall, the studies did not find a significant difference with regard to overall survival between tamoxifen alone, tamoxifen plus ovarian suppression, or aromatase inhibitors (AIs) plus ovarian suppression. The guideline update was published in the Journal of Clinical Oncology.”


The Growing Arsenal of Immunotherapy Drugs for Melanoma


Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic‘ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type. As a consequence, metastatic melanoma is no longer the universally fatal disease it was even just 3 or 4 years ago. Continue reading…