The ASCO Daily News aims to bring you the most scientific coverage from the 2017 Annual Meeting. Here are some bite-sized articles from Saturday's ASCO Daily News coverage.
Patient and Survivor Care
Poster Session (Abstract 10088)
First Author: Julia R. Nangia, MD
Scalp cooling to prevent chemotherapy-induced alopecia was highly effective in a multicenter randomized trial that enrolled women with stage I-II breast cancer. The trial evaluated the safety and efficacy of the Orbis Paxman hair loss prevention system.
The trial enrolled women who were expected to receive anthracycline- or taxane-based chemotherapy for at least four cycles and randomly assigned them in a 2-to-1 manner to scalp cooling or to control. Scalp cooling was performed 30 minutes before, during, and 90 minutes after each chemotherapy treatment. The primary efficacy endpoints were hair preservation and device safety. Patients will be observed for 5 years for recurrence, OS, and site of recurrence.
An interim analysis found that 48 (50.5%) of 95 patients in the scalp-cooling group had hair preservation compared with none of 47 patients in the control group (p < 0.0001). Those results prompted the Data and Safety Monitoring Board to stop the trial early in September 2016.
The U.S. FDA cleared the company to market the scalp cooling system in April 2017.
Patient and Survivor Care
Poster Discussion Session (Abstract 10020)
First Author: Karen Michelle Mustian, PhD, MPH
A nationwide, multicenter, phase III, randomized controlled trial suggests that participation in Exercise for Cancer Patients (EXCAP) can protect against chemotherapy-induced muscle damage through its effects on serum proteins. The changes in these novel biomarkers may mediate changes in cancer-related fatigue.
The trial enrolled 350 patients with cancer, mean age 55.7, from 39 community oncology practices affiliated with the URCC NCORP Research Base. All patients, chemotherapy-naive at enrollment, were randomly assigned to either chemotherapy alone or chemotherapy plus a prescription for the 6-week EXCAP aerobic and resistance exercise program. Assessment of patient mRNA gene expression, serum protein levels of MYL5 and MYH8, and cancer-related fatigue were conducted pre- and post-intervention. Secretion of MYL5 and MYH8 proteins into serum can indicate degradation of muscle and subsequent cancer-related fatigue.
MYL5 and MYH8 levels were significantly increased in the control group from pre- to post-intervention (p < 0.05), but the levels remained stable in patients randomly assigned to the chemotherapy-plus-exercise group. The significant differences between the two groups suggest greater muscle degradation in the group that did not exercise, and Pearson correlations revealed trends suggesting that increases in MYL5 and MYH8 serum proteins are associated with increases in cancer-related fatigue.
Gastrointestinal (Noncolorectal) Cancer
Poster Discussion Session (Abstract 4019)
First Author: Thomas Ruhstaller, MD
Adding neoadjuvant and adjuvant cetuximab to a multimodal therapy reduced locoregional recurrences and showed a clinically relevant improvement in PFS and OS in patients with resectable esophageal carcinoma.
In the intergroup, open-label, randomized phase III trial SAKK 75/08, 300 patients received two cycles of induction chemotherapy (75 mg/m2 docetaxel and 75 mg/m2 cisplatin) followed by chemoradiation (45 Gy, 20 mg/m2 docetaxel and 25 mg/m2 cisplatin weekly) plus surgery, or the same treatment plus neoadjuvant weekly treatment with 250 mg/m2 of cetuximab and adjuvant biweekly treatment with 500 mg/m2 of cetuximab for 3 months. The median age of the patients was 61, and 88% were men. Primary endpoint was PFS.
There was no statistically significant difference in median PFS between the two groups; median PFS was 48% at 4 years in the cetuximab arm compared with 37% in the control arm (HR 0.79, 95% CI [0.58, 1.07]; p = 0.13). Median OS at 4 years was 56% in the cetuximab arm and 43% in the control arm (HR 0.73, 95% CI [0.52, 1.01]; p = 0.055).
Gastrointestinal (Colorectal) Cancer
Poster Session (Abstract 3518)
First Author: Ji Won Park, MD
The long-term oncologic safety of laparoscopic surgery for rectal cancer was demonstrated in a 7-year follow-up analysis of data from the COREAN trial. COREAN compared laparoscopic surgery with open surgery for mid- or low-rectal cancer after neoadjuvant chemoradiotherapy. In this noninferiority, randomized, controlled trial, 170 patients were assigned to laparoscopic surgery and 170 to open surgery.
The median follow-up time for the long-term analysis was 84 months, and outcomes included OS, DFS, and local recurrence. There were no differences between laparoscopic and open surgery in OS, DFS, or local recurrence at the 7-year follow-up.
At 7 years, OS was 83.2% for patients treated with laparoscopic surgery vs. 77.3% with open surgery (hazard ratio [HR] 0.96, 95% CI [0.58, 1.57]; p = 0.48). DFS was 71.6% with laparoscopic vs. 64.3% with open surgery (HR 1.03, 95% CI [0.70, 1.53]; p = 0.20). Local recurrence was 3.3% with laparoscopic vs. 7.9% with open surgery (HR 2.28, 95% CI [0.82, 7.16]; p = 0.08). There were no significant differences in OS, DFS, or local recurrence between the groups when analysis was adjusted for ypT and ypN status and for regression grade.