Breast Cancer: No Survival Benefit From IM-MS Irradiation

Fifteen-year results of a randomized phase 3 trial show that for patients with stage I–III breast cancer, internal mammary and medial supraclavicular (IM-MS) lymph node chain irradiation reduces breast cancer mortality and breast cancer recurrence but does not produce a significant improvement in overall survival. "Ten-year results from several studies showed improved disease-free survival and distant metastasis-free survival, reduced breast cancer-related mortality, and variable effects on over...
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Nivolumab/Ipilimumab for Malignant Pleural Mesothelioma: Paul Baas, MD, PhD

The FDA recently approved nivolumab/ipilimumab for the first-line treatment of malignant pleural mesothelioma, marking the second FDA approval for this condition and the first approval in the past 16 years. In this interview, Paul Baas, MD, PhD, principal investigator of the CheckMate 743 trial (NCT02899299), on which the approval was based, speaks with Oncology Data Advisor about the benefits and tolerability of nivolumab/ipilimumab, ongoing research advances in the treatment of malignant pleur...
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FDA Issues Draft Guidances for Bladder Cancer, Renal Cell Carcinoma

The FDA has issued draft guidance documents for drug and biologic development in the adjuvant treatment of renal cell carcinoma (RCC) and bladder cancer, with recommendations for clinical trials concerning eligibility criteria, methodology, and use of disease-free survival as an end point. "The FDA has actively encouraged a more uniform approach to developing clinical trials to evaluate adjuvant treatments for renal cell carcinoma and bladder cancer, including hosting a public workshop in p...
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Nivolumab/Ipilimumab Approved: Malignant Pleural Mesothelioma

The FDA has now approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with ipilimumab (Yervoy®, Bristol-Myers Squibb) as first-line treatment for unresectable malignant pleural mesothelioma (MPM). This therapeutic combination is only the second treatment to be FDA approved for this condition, and it marks the first mesothelioma approval to take place in the past 16 years. The approval was based on efficacy data from the open-label phase 3 CHECKMATE 743 trial (NCT02899299), ...
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Nivolumab Plus Chemotherapy for Gastric/Gastroesophageal Junction Cancer: Kohei Shitara, MD

In advanced gastric cancer and gastroesophageal junction cancer, treatment options remain limited. Results of the phase 3 CheckMate 649 and phase 2/3 ATTRACTION-4 studies, both of which investigated chemotherapy with or without nivolumab in patients with previously untreated unresectable, advanced, or recurrent gastric/gastroesophageal junction (G/GEJ) cancer, were recently presented at the European Society of Medical Oncology (ESMO) Virtual Congress 2020. CheckMate 649 reported significant impr...
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