
Top News From ESMO 2017: Slideshow
The revolution in cancer therapy that is targeted therapy and immunotherapy continued at the European Society for Medical Oncology (ESMO) 2017 Congress, held September 8 to 12 in Madrid, Spain. New data show that the drugs are effective not only in the palliative setting but also in earlier stages of disease.
Top News From ESMO 2017: Slideshow
ESMO 2017 drew an estimated 23,000 attendees and featured 1500 original abstracts submitted by researchers from across the globe. Among the key presentations were the following:
- Immunotherapy changes first-line paradigm in advanced RCC
- New adjuvant option for BRAF melanoma
- Clear benefit with adjuvant nivolumab in resected melanoma
- Abemaciclib: first-line CDK4/6 inhibitor for breast cancer
- Chemoradiotherapy remains standard of care in cervical cancer
- Osimertinib poised to be new first-line standard in EGFRm, NSCLC
- Hint of survival gain with ramucirumab in urothelial cancer
- Cancer patients struggle to understand clinical trials
Top News From ESMO 2017: Slideshow
Immunotherapy Changes First-Line Paradigm in Advanced RCC
New data are set to change the paradigm for the first-line treatment of advanced RCC, after a phase 3 trial showed significantly improved overall survival with immunotherapy in comparison to standard care with sunitinib (Sutent, Pfizer). The data come from the CheckMate-214 study, which the data monitoring committee stopped early after it showed that patients with advanced RCC were living significantly longer when treated first line with the combination of nivolumab (Opdivo, Bristol-Myers Squibb) and ipilimumab (Yervoy, Bristol-Myers Squibb). Until now, nothing has beaten sunitinib in a randomized phase 3 clinical trial, and it was "brave to choose it as a comparator," said study discussant Manuela Schmidinger, MD, from the Medical University of Vienna, Austria. Reacting to the new findings, Maria de Santi, MD, University of Warwick, United Kingdom, was enthusiastic. "This means that immunotherapy is not only a new option for these patients, it should become the standard of care," she told Medscape Medical News.
Top News From ESMO 2017: Slideshow
New Adjuvant Option for BRAF Melanoma
Results from the COMBI-AD phase 3 study have established a new standard for adjuvant treatment of melanoma with BRAF mutations, say experts. With these data, the combination of dabrafenib (Tafinlar, Novartis) and trametinib (Mekinist, Novartis) moves up front from the metastatic to the adjuvant setting. In patients with surgically resected BRAF V300–positive melanoma, 1 year of oral adjuvant therapy with the combination provided a 53% lower risk for 3-year recurrence compared with placebo. "The efficacy and tolerability of dabrafenib in combination with trametinib seen in this study represent an important step forward," said lead investigator, Axel Hauschild, MD, PhD, from University Hospital Schleswig-Holstein, Kiel, Germany. "These unprecedented results confirm a targeted therapy combination has the potential to transform the standard of care in the melanoma adjuvant setting," he added. ESMO expert Dummer Reinhard, MD, from University Hospital of Zürich, Switzerland, said the results "will change guidelines for patients with melanoma in the adjuvant setting and provide two new treatment options for these patients."
Top News From ESMO 2017: Slideshow
Clear Benefit With Adjuvant Nivolumab in Resected Melanoma
Patients with melanoma who have successfully undergone resection but are at high risk for relapse have substantially better outcomes with nivolumab (Opdivo) than the current standard-of-care ipilimumab (Yervoy), according to new results from the phase 3 CheckMate-238 study, which was stopped early owing to benefit. Adjuvant nivolumab increased relapse-free survival by a significant 35% compared with adjuvant ipilimumab while also reducing the rate of grade 3 or higher adverse effects by approximately a third. "Nivolumab clearly showed a very clinically and statistically significant improvement in relapse-free survival vs high-dose ipilimumab for patients with surgically resected stages IIIB, IIIC, and IV melanoma. The benefit for nivolumab was observed for virtually all of the prespecified subgroups," said Jeffrey S. Weber, MD, PhD, from NYU Langone Medical Center, New York City. He also noted the superior safety profile of nivolumab in comparison with ipilimumab.
Top News From ESMO 2017: Slideshow
Abemaciclib: First-Line CDK4/6 Inhibitor for Breast Cancer
Abemaciclib (Lilly), the third in the class of cyclin-dependent kinase (CDK) 4/6 inhibitors, has shown positive results in the phase 3 MONARCH 3 study of its use in the first-line treatment of treatment-naive postmenopausal women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer. The results show that the addition of abemaciclib to anastrazole or letrozole was associated with significantly prolonged progression-free survival. The MONARCH 3 study, presented by Angelo Di Leo, MD, PhD, from Hospital of Prato, Istituto Toscano Tumori, Italy, is expected to provide a front-line indication for abemaciclib as combination therapy. However, abemaciclib is not yet on the market, and the new drug application with the US Food and Drug Administration for abemaciclib is based on results from both the MONARCH 2 and the MONARCH 1 study. In those studies, abemaciclib monotherapy demonstrated objective responses in women with HR+/HER2– advanced or metastatic breast cancer that had progressed after one or more endocrine-based therapies.
Top News From ESMO 2017: Slideshow
Chemoradiotherapy Remains Standard of Care in Cervical Cancer
Patients with locally advanced cervical cancer should continue to be treated with chemoradiotherapy and not be initially offered chemotherapy alone followed by radical surgery, advised Indian researchers who compared the two approaches in a randomized controlled trial. For the past 20 years, the standard of care in locally advanced cervical cancer has been radiotherapy and simultaneous treatment with cisplatin (Platinol, HQ Specialty). However, up to 40% of women experience a relapse after treatment, prompting interest in neoadjuvant chemotherapy followed by radical surgery (NACT-surgery), particularly because older trials that compared the more invasive approach with radiotherapy alone yielded positive results. However, the new trial, which included more than 600 patients with cervical cancer, showed that during a 5-year period, NACT-surgery was associated with a significant increase of almost 40% in rates of relapse or death vs standard chemoradiotherapy. The study was presented by Sudeep Gupta, MD, PhD, from Tata Memorial Center, Mumbai, India.
Top News From ESMO 2017: Slideshow
Durvalumab Boosts PFS Even in Stage III Lung Cancer
Immunotherapy could be the new standard of care in patients with stage III, locally advanced non-small cell lung cancer (NSCLC) in whom chemoradiotherapy has failed, after a trial showed that the programmed cell death ligand 1 inhibitor durvalumab (Imfinzi, AstraZeneca) is effective in this hard-to-treat population. Up to 35% of patients with NSCLC present with stage III, locally advanced disease that is, in most cases, unresectable. At present, the standard of care in this group is platinum-based doublet chemotherapy and concurrent radiotherapy, yielding a median progression-free survival (PFS) of 8 to 10 months, with only 15% of patients alive at 5 years. The new results, from the PACIFIC study, showed that giving durvalumab after chemoradiotherapy doubled PFS over placebo, increasing it by 11 months. Moreover, just less than half of durvalumab-treated patients were still alive 18 months after starting treatment. This is the first randomized controlled trial of an immunotherapy in this clinical setting, noted lead author, Luis Paz-Ares, MD, PhD, from Hospital Universitario 12 de Octubre, CiberOnc, Universidad Complutense and CNIO, Madrid, Spain.
Top News From ESMO 2017: Slideshow
Osimertinib Poised to Be New First-line Standard in EGFR Mutated NSCLC
Osimertinib (Tagrisso, Astra-Zeneca), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), provided significant improvement in PFS over current standard-of-care therapies in advanced NSCLC harboring EGFR mutations in the first-line setting. Compared with those receiving standard of care, patients receiving osimertinib in the phase 3 FLAURA study were at a 54% reduced risk for progression. At this time, osimertinib is approved to treat patients with advanced NSCLC with the EGFR T790M mutation who have progressed while receiving prior EGFR TKI therapies. These new data from FLAURA provide strong support for its use in the first-line setting across other sensitizing EGFR mutations as well. "The FLAURA data for osimertinib are likely to result in a major paradigm shift in the treatment of patients with EGFR mutation–positive advanced lung cancer," said lead author, Suresh S. Ramalingam, MD, from Winthrop Cancer Institute, Emory University, Atlanta, Georgia. "Not only did the trial demonstrate a robust improvement in efficacy with osimertinib when compared to other commonly used EGFR inhibitors, the side effects profile was also more favorable with osimertinib."
Top News From ESMO 2017: Slideshow
Alectinib Activity in CNS Metastases in Patients With ALK+ NSCLC
Impressive activity against central nervous system (CNS) metastases has been shown again with the targeted agent alectinib (Alecensa, Roche/Genentech) in patients with ALK-positive NSCLC. The new data come from the ALUR and ALEX studies. ALEX uses alectinib in the first-line setting, and ALUR uses it in the latter lines of therapy. A subanalysis of ALEX showed that patients with measureable CNS disease at baseline were at a 60% reduced risk for progression with alectinib compared with crizotinib (Xalkori, Pfizer). ALUR showed that in patients with measurable CNS disease at baseline, CNS overall response rate was 54% for patients receiving alectinib and 0% for patients receiving chemotherapy. "The results of the ALUR and ALEX trials provide proof of clinically significant CNS efficacy for alectinib and indicate that CNS staging should be routine for optimal care of patients with ALK+ lung cancers," said Fiona Blackhall, MD, PhD, from the University of Manchester, United Kingdom. Alectinib is approved for second-line use to treat ALK-positive NSCLC that has progressed on crizotinib.
Top News From ESMO 2017: Slideshow
No Need for CT Scans in NSCLC Postsurgery Follow-up?
Current recommendations for computed tomographic (CT) scanning as part of ongoing follow-up for patients with completely resected NSCLC have been questioned after data from a randomized trial showed that the practice offers no overall survival benefit. Major international guidelines recommend intensive follow-up, including CT scans, every 3 to 6 months during the first 2 years after successful surgery. But a group of French researchers from the Intergroupe Francophone de Cancerologie Thoracique (IFCT) have shown that less intensive follow-up with clinical examinations and chest radiography achieves similar survival rates. The finding comes from the IFCT-0302 study, a randomized, controlled trial of more than 1700 patients who underwent complete resection for stage I, II, or IIIA NSCLC. Because there was no overall difference in survival with either type of follow-up, "both follow-up protocols are acceptable," said lead author, Virginie Westeel, MD, PhD, from Centre Hospitalier Régional Universitaire, Hôpital Jean Minjoz, Besançon, France.
Top News From ESMO 2017: Slideshow
Hint of Survival Gain With Ramucirumab in Urothelial Cancer
Patients with advanced or metastatic urothelial cancer who have progressed on platinum-based chemotherapy have a significant increase in disease-free survival with an angiogenesis inhibitor, suggest the results of a phase 3 trial. The vascular endothelial growth factor receptor 2 antibody ramucirumab (Cyramza, Lilly) significantly increased PFS by almost 25% compared with placebo. The new results come from the RANGE study. Lead author, Daniel P. Petrylak, MD, from Yale School of Medicine, New Haven, Connecticut, said the reduction in the risk for disease progression was consistent across patient subgroups. "The objective response rate nearly doubled with ramucirumab, and there were no significant differences in toxicities between treatments," Dr Petrylak reported. However, the absolute benefit seen with the drug was small, and quality of life did not improve, leading some experts here to question the clinical relevance of the treatment in this traditionally hard-to-treat group of patients.
Top News From ESMO 2017: Slideshow
Cancer Patients Struggle to Understand Clinical Trials
Patients with cancer struggle to digest what is involved in a clinical trial, even when they have participated in one. In a survey of 1090 adult patients with cancer, more than half did not understand the concepts of clinical equipoise or randomization; 63% of patients thought that "my doctor would make sure that I got the better treatment in a clinical trial," and 55% said that "my doctor would know which treatment in a clinical trial was better." The results were rather surprising, said lead author, Catherine Kelly, MD, from University College in Dublin, Ireland, because even patients who had been in a clinical trial still felt that the treating physician would choose the best treatment and, even more worrying, that the physician would make sure that they were getting the best treatment. These responses show that patients "very much trust their cancer doctors, with the expectation that the doctor will know what is the best treatment and will ensure that they get it," Dr Kelly said. The findings suggest that oncologists and their research teams need to explain these concepts more clearly and indicate a need for more training of communication skills, she said.
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