The ASCO Post | JULY 25, 2013
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ASCO Annual Meeting New Research Presented in Breast, Gastric, Esophageal Cancers, Melanoma, and Multiple Myeloma, plus Supportive Care By Caroline Helwick and Alice Goodman
BOLERO-3, which included 569 patients who received everolimus daily plus vinorelbine and trastuzumab weekly, or vinorelbine/trastuzumab alone. All had received prior taxane
© ASCO/Todd Buchanan 2013
A
ttendees at the ASCO Annual Meeting are faced with a major challenge of trying to attend as many important sessions as they can over a 4-day period. Our challenge is to feature the major news in The ASCO Post. In addition to our regular comprehensive coverage of key presentations, the following selected highlights describe other noteworthy studies of interest.
BOLERO-3: mTOR Inhibition in Breast Cancer The addition of everolimus (Afinitor) to therapy improved progressionfree survival in patients with HER2-positive, trastuzumab (Herceptin)-resistant, taxane-pretreated advanced breast cancer in the BOLERO-3 trial.1 However, clinical benefit rates were not improved, suggesting that the overall benefit of this treatment approach may be less than striking. Ruth O’Regan, MD, of Emo-
Ruth O’Regan, MD
ry University School of Medicine, Atlanta, presented the results of
Kimberly L. Blackwell, MD
therapy, and 27% had received prior lapatinib (Tykerb). The study met its primary endpoint. Everolimus improved median progression-free survival to 7.0 months, a small increase from 5.78 months with placebo (hazard ratio [HR] = .78; P = .0067). Subgroup analyses suggested the benefits were greatest among patients younger than age 65, those with hormone receptor–negative tumors, and those who had received prior adjuvant or neoadjuvant trastuzumab. Response rates and stable disease rates were not significantly different between the groups, and overall survival data were not mature. Discussant Kimberly L. Blackwell, MD, of the Duke Cancer Institute, Durham, North Carolina, said the role for mTOR inhibition in this patient population remains unclear after the study. The lack of effect on overall survival (to date) or clinically meaningful
Brief Reports from ASCO 2013 ■ Everolimus improved median progression-free survival in patients with
HER2-positive, trastuzumab-resistant, taxane-pretreated advanced breast cancer in the BOLERO-3 trial, but clinical benefit rates were not improved.
■ In patients with HER2-positive advanced or metastatic gastric, esophageal, or gastroesophageal adenocarcinoma, adding lapatinib to CapeOx (capecitabine plus oxaliplatin) failed to improve overall survival in the TRIO-013/LOGiC trial.
■ Among patients with newly diagnosed multiple myeloma, treatment
with high-dose melphalan and autologous transplantation, followed by lenalidomide maintenance therapy produced the best progression-free survival in a four-arm comparison.
■ Half of advanced melanoma patients receiving lambrolizumab at its
optimal dose responded to the anti-PD-1 monoclonal antibody in an openlabel trial.
outcomes makes it difficult to call for a change to the standard of care, despite the improvement in progression-free survival, she maintained. “There are other HER2-targeted agents that do provide a documented overall survival benefit,” including the combination of docetaxel, trastuzumab, and pertuzumab (Perjeta), Dr. Blackwell noted.
Lapatinib plus CapeOx in Gastric, Esophageal Cancer In patients with HER2-positive advanced or metastatic gastric, esophageal, or gastroesophageal adenocarcinoma, the addition of lapatinib to CapeOx (capecitabine [Xeloda] plus oxaliplatin) failed to improve overall survival, the primary endpoint of the TRIO-013/LOGiC trial, presented by J. Randolph Hecht, MD, of the David Geffen School of Medicine at the University of California, Los Angeles.2 In the study of 545 patients, median overall survival was 12.2 months with lapatinib plus CapeOx, vs 10.5 months
J. Randolph Hecht, MD
with CapeOx alone (HR .91; P = .35). Median progression-free survival was 6.0 vs 5.4 months, respectively (HR = .86; P = .10), though in an analysis that censored patients from the start of second-line therapy, a benefit was observed with the lapatinib-containing regimen (HR = .82; P = .04). “In subgroup analyses, patients from Asia and those younger than age 60 experienced an increased effect from lapatinib,” Dr. Hecht added. The median overall survival in Asian patients improved from 10.9 months with CapeOx alone to 16.5 months with lapatinib added (HR = .68). In younger patients, median overall survival improved from 9.0 to 12.9 months (HR = .69). Serious adverse events were more common in the lapatinib-containing arm (27%
vs 19%) as were fatal adverse events (6% vs 3%).
Early Transplant plus Maintenance in Multiple Myeloma In patients with newly diagnosed multiple myeloma, treating with highdose melphalan and autologous transplantation (MEL200), followed by maintenance therapy with lenalidomide (Revlimid), resulted in the best progression-free survival in a four-
Antonio Palumbo, MD
arm comparison reported by Antonio Palumbo, MD, of the University of Torino, Italy.3 In fact, each of the two components of this strategy was independently associated with improvement. The trial randomly assigned 402 patients aged 65 or younger to the combination of melphalan, prednisone, and lenalidomide (MPR) or MEL200, and subsequently to maintenance with lenalidomide or no maintenance. Median progression-free survival was 38 months with MEL200 vs 24 months with MPR, with MEL200 providing an additional 14 months of remission (HR = 1.69; P < .0001). Overall survival was not different, but longer follow-up may be required, Dr. Palumbo suggested. For the secondary randomization, response rates were similar whether patients received lenalidomide maintenance or not. However, patients receiving maintenance therapy had a significantly longer progression-free survival (37 vs 26 months: HR = .52; P < .0001) and, at 5 years, a difference in overall survival as well (75% vs 58%; HR = .62; P = .02). Sagar Lonial, MD, of Emory University, who discussed the paper, commented, “It appears pretty clear from these data that the benefit of