
Top News From ESMO 2018: Slideshow
Landmark trials that could change the face of management for head and neck cancer, triple-negative breast cancer, renal cell carcinoma, and ovarian cancer greeted the nearly 20,000 attendees from over 300 countries here at the European Society for Medical Oncology (ESMO) 2018 Congress, held in Munich, Germany, October 19 to 23.
Top News From ESMO 2018: Slideshow
More than 2050 abstracts were presented over 5 days, covering the latest in immunotherapy, future technologies, biomarkers, basic and translational research, prevention and more. Among the highlights:
- Immunotherapy shows promise for the first time in triple-negative breast cancer
- "Outstanding" ovarian cancer progression-free survival with a PARP inhibitor
- Proven benefit of prostate RT in some men with newly diagnosed metastatic disease
- Chemo-free therapy for head and neck cancer a step closer
- Adding immunotherapy to targeted therapy up front improves PFS in kidney cancer
- Clear gender differences in chemotherapy side effects
- New data on male breast cancer suggest current clinical practice is justified
Top News From ESMO 2018: Slideshow
New Hope in Triple-Negative Breast Cancer With Immunotherapy
For the first time, immunotherapy has shown a survival benefit in breast cancer. The result was seen with the anti–programmed cell death ligand 1 (PD-L1) drug atezolizumab (Tecentriq, Genentech) used with chemotherapy in triple-negative breast cancer in PD-L1-positive (PD-L1+) patients. The results, from the IMpassion130 study, were presented by Peter Schmid, MD, PhD, clinical director of St. Bartholomew's Breast Cancer Center, Barts Health NHS Trust, London, United Kingdom and were simultaneously published in the New England Journal of Medicine. The trial randomly assigned more than 900 women who had triple-negative disease to receive atezolizumab or placebo plus chemotherapy as first-line therapy. Across the board, the addition of atezolizumab was associated with a 20% improvement in progression-free survival (PFS). However, when the researchers assessed a subgroup of patients who were PD-L1+, the addition of atezolizumab improved PFS by 38% and increased overall survival by the same percentage, offering patients an additional 10 months of life in comparision with the patients who received chemotherapy alone.
Top News From ESMO 2018: Slideshow
"Outstanding" Ovarian Cancer PFS With Olaparib Maintenance
A first-of-its kind phase 3 study found that for patients with advanced ovarian cancer who carry a BRCA mutation, PFS os markedly increased if they are given maintenance therapy with the PARP inhibitor olaparib (Lynparza, AstraZeneca) following successful first-line chemotherapy. In the SOLO1 study, Kathleen Moore, MD, from the Stephenson Cancer Center, University of Oklahoma, and colleagues found that after more than 3 years of follow-up, olaparib was associated with a 70% increase in PFS compared with placebo, caused few toxicities, and had no impact on quality of life. Noting that the "outstanding" improvement in PFS was maintained even after stopping treatment at 2 years, Moore said that the findings "herald a new era in treatment for women diagnosed with advanced ovarian cancer who carry a BRCA mutation." She added, "While it is too early to say whether we have impacted the fraction of women who could be cured with their frontline therapy, the fact that it is estimated that over 50% of women in the olaparib arm were still progression free at 4 years as compared to only 11% for placebo speaks to this hope."
Top News From ESMO 2018: Slideshow
New Data on RT in Prostate Cancer Are "Practice Changing"
Radiotherapy to the prostate on top of standard hormonal therapy significantly improved overall survival (OS) for men with newly diagnosed metastatic prostate cancer (mPCa) with low metastatic burden, according to new data from the STAMPEDE trial. However, only this subgroup of patients had the benefit; the OS benefit did not extend to the total unselected population of men with newly diagnosed mPCa. "Prostate radiation therapy should be the standard of care for men with low metastatic burden," commented lead investigator Christopher C. Parker, MD, of the Royal Marsden NHS Foundation Trust, London, United Kingdom. "Until now, it was thought that there was no point in treating the prostate itself if the cancer had already spread because it would be like shutting the stable door after the horse has bolted," Parker said at the press conference. "However, this study proves the benefit of prostate radiotherapy for these men. Unlike many new drugs for cancer, radiotherapy is a simple, relatively cheap treatment that is readily available in most parts of the world," he added.
Top News From ESMO 2018: Slideshow
Chemo-Free Therapy for Head and Neck Cancer a Step Closer
Patients with recurrent or metastatic head and neck cancer with relatively high expression of the PD-L1 could eventually be treated first line with the immunotherapy pembrolizumab (Keytruda, Merck) rather than traditional chemotherapy. This was the conclusion from experts discussing the results of KEYNOTE-048, the first study to assess immunotherapy used first line in this patient population. The new results show an improvement in overall survival over initial use of standard of care chemotherapy — the first time such a benefit has been seen in 10 years, the investigators noted. Immunotherapy is already used second line in advanced head and neck cancer; pembrolizumab and the similar drug nivolumab (Opdivo, Bristol-Myers Squibb) are already approved for this indication. The KEYNOTE-048 results show that "patients with PD-L1 expression live longer when they have initial treatment with pembrolizumab," said study lead Barbara Burtness, MD, Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut.
Top News From ESMO 2018: Slideshow
Immunotherapy Plus Targeted Drug in First-Line Kidney Cancer
Adding immunotherapy to a targeted agent significantly improved progression-free survival (PFS) when compared with a targeted agent alone in the first-line treatment of advanced renal cell carcinoma (RCC), suggests interim results from the JAVELIN Renal 101 trial. The combination therapy, comprised of the anti-PD-L1 drug avelumab (Bavencio, EMD Serono) and the vascular endothelial growth factor tyrosine kinase inhibitor axitinib (Inlyta, Pfizer), was pitted against the current standard of care, sunitinib (Sutent, Pfizer). Combination therapy improved median PFS by 39% in patients who tested positive for PD-L1 expression and by 31% in the overall patient population. The objective response rate with avelumab plus axitinib was not quite twice that seen with sunitinib, and the combination therapy had a favorable safety profile. As this was a preliminary analysis, the overall survival data are immature, although there was a signal for an increase in median overall survival. Study presenter Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, New York City, said the findings "support the potential of avelumab plus axitinib as a new treatment approach for patients with advanced RCC."
Top News From ESMO 2018: Slideshow
Novel PI3K Inhibitor for Breast Cancer: Success at Last?
A new and highly selective inhibitor of phosphatidylinositol-3-kinase (PI3K) has shown benefit in advanced breast cancer and may succeed where two previous drugs aimed at the same target failed. The new investigational drug alpelisib (Novartis) is an alpha-specific PI3K inhibitor that blocks only the alpha-isoform of the enzyme, which is the one that is mutated in breast cancer. "Previous PI3K inhibitors targeted all four isoforms, so there were a lot of toxicities," explained Fabrice André, MD, PhD, of Institut Gustave Roussy, Villejuif, France. He was lead investigator of the phase 3 SOLAR-1 trial, conducted in postmenopausal women and men with advanced breast cancer that was hormone-receptor positive (HR+) and HER2 negative and who tested positive for PIK3CA mutations (314 of 572 of trial participants, 54.8%). The PIK3CA mutation activates the PI3 kinase pathway, leading to cancer progression and resistance to endocrine therapy, he explained. In the patients who had the mutation, the combination of alpelisib plus endocrine therapy with fulvestrant almost doubled PFS compared with fulvestrant alone. There was no benefit in patients who did not have the mutation. "Alpelisib is the first drug to show a benefit in a genomic subgroup of breast cancer patients," André said.
Top News From ESMO 2018: Slideshow
Palbociclib in Breast Cancer: New Overall Survival Data
The new class of cyclin-dependent kinase (CDK) 4/6 inhibitors offer hope for patients with advanced breast cancer who have stopped responding to endocrine therapy. In the PALOMA-3 trial, conducted in patients with advanced HR+, HER2- breast cancer who had stopped responding to endocrine therapy, adding palbociclib (Ibrance, Pfizer) to fulvestrant improved OS by 7 months compared with fulvestrant alone. For patients with prior endocrine sensitivity, the difference in median OS with palbociclib and fulvestrant was 10 months. The primary endpoint for median progression-free survival (PFS) was reported previously and was significant for the combination. Massimo Cristofanilli, MD, of the Feinberg School of Medicine, Northwestern University, Chicago, Illinois, indicated that for patients with advanced HR+, HER2- breast cancer whose disease has progressed or relapsed with prior endocrine therapy, the combination of palbociclib and fulvestrant should be the standard of care.
Top News From ESMO 2018: Slideshow
Details of Study That Led to Radium-223 Restriction in Europe
Details of the ERA 223 clinical trial, which led to a restriction in Europe of the use of the radiopharmaceutical radium-223 dichloride (Ra-223; Xofigo, Bayer), were presented by Matthew Smith, MD, of the Massachusetts General Hospital Cancer Center, Boston. The trial was unblinded early after a signal of a higher fracture rate and increase in deaths. ERA 223 was conducted in men with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. The higher fracture rate was seen in the group who received Ra-223 with abiraterone acetate (Zytiga, Janssen Oncology) and prednisone/prednisolone (AAP); the fracture rate was 26%, compared with 10% for those who received AAP alone. As a result of this finding, in July 2018, the European Medicines Agency aligned with its Pharmacovigilance Risk Assessment Committee and recommended restricting the use of Ra-223 to patients who had received two previous treatments for metastatic prostate cancer with bone metastases or to those who could not use any other treatment. "The combination of Ra-223 and AAP cannot be recommended as first-line treatment for patients with mCRPC," said Daniel Heinrich, MD, of Akershus University Hospital in Lørenskog, Norway.
Top News From ESMO 2018: Slideshow
Sex Differences in Chemo Side Effects
Women who receive first-line chemotherapy for esophagogastric cancer are more likely to experience a range of adverse effects and toxicities than men treated with the same regimens, report UK researchers led by Michael Davidson, MD, of the Royal Marsden Hospital National Health Service Foundation Trust, London. They examined data from four trials involving more than 1600 patients treated with one of four chemotherapy regimens. Women were much more likely than men to report all-grade and severe nausea and vomiting, as well as all-grade diarrhea, mouth ulceration, and hair loss, despite the fact that overall rates of all-grade and severe toxicity were similar. Rates of peripheral neuropathy were higher in men than women. There were no significant differences in survival between men and women, although the overall response rate was higher in men than in women. The difference was of borderline statistical significance. Davidson said the "key finding" is that men and women "were affected by a number of different toxicities to varying degrees," despite receiving similar chemotherapy combinations. He added, however, that "the clinical relevance of this remains to be established."
Top News From ESMO 2018: Slideshow
Male Breast Cancer: Current Clinical Practice "Justified"
Despite the fact that male breast cancer patients are, on average, older than their female counterparts and that the disease profiles of male breast cancer and female breast cancer differ at diagnosis, male breast cancer patients appear to respond just as well to the same treatments as those given to women, suggest data from several new studies presented as posters here. The new data were welcomed by experts, who pointed out that male breast cancer is a rare disease for which there is a paucity of data both on incidence and treatment outcomes. One study examined data from the National Cancer Institute's SEER Program on all 6790 men diagnosed with breast cancer in the United States over 15 years. Commenting for ESMO, Agnes Jager, MD, PhD, from Erasmus Medical University Cancer Institute, Rotterdam, the Netherlands, said that such a large study in men with primary breast cancer "was missing until now. This new study shows the prognosis of men and women is similar, which is of great value, as this justifies our current clinical practice," she said. "We currently treat men with breast cancer in a similar way to women, which is now supported by these data."
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