CHICAGO — “Patients who feel better, live longer.” And, to help patients feel better, clinicians need to provide optimal symptom management, said Eric Roeland, MD, GI Oncology & Palliative Care, UC San Diego Moores Cancer Center, San Diego, California, discussant for 4 poster presentations at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting.
The presentations focused on constipation, fatigue, peripheral neuropathy, and nausea and vomiting; for each, Dr. Roeland reported whether he believed the results to be “clinically meaningful.”
Harada et al1 conducted a phase 3 study to evaluate the efficacy and safety of naldemedine, a peripherally-acting μ-opioid receptor antagonist currently in development for the treatment of opioid-induced constipation. They found that naldemedine resulted in a 71% increase in spontaneous bowel movements, compared with 34% for placebo (P < .001), and was well tolerated.
Is this clinically meaningful? “Yes,” said Dr. Roeland.
The second presentation reviewed results of a phase 2 randomized trial of minocycline to reduce chemoradiation-related fatigue in patients with non-small cell lung cancer. Cleeland et al2 found that minocycline, when administered during concurrent chemoradiation therapy, “was feasible, had a low toxicity profile, and yielded a statistically significant positive signal in terms of patient-reported fatigue.”
Is this clinically meaningful? “I don’t know,” said Dr. Roeland, adding that next steps include a phase 3 trial. He said lack of an inflammatory biomarker and lack of tumor assessment data represent future opportunities.
Glimelius et al3 examined persistent prevention of chemotherapy-induced peripheral neuropathy (CIPN) using calmangafodipir in a phase 2 study in patients with metastatic colorectal cancer treated with oxaliplatin. They found the agent to be “promising in preventing acute and persistent CIPN without any detectable negative influence on the antitumor activity of an oxaliplatin-5FU combination in patients with metastatic colorectal cancer.” A phase 3 trial is planned.
Is this clinically meaningful? “We’ll see,” said Dr. Roeland.
The fourth presentation, by Matsuzaki et al,4 compared dexamethasone day 1 to day 1 to 3 as a component of antiemetic therapy for chemotherapy-induced nausea and vomiting and found that its administration can be limited to day 1 for highly emetogenic chemotherapy.
Is this clinically meaningful? “Yes,” said Dr. Roeland. “I think this is practice-changing for many of us.” He recommended that future studies evaluate patient-specific CINV risk factors and that dexamethasone-specific side effects be attributed.
1. Harada T, Katakami N, Murata T, et al. Phase 3 study to evaluate the efficacy and safety of naldemedine for the treatment of opioid-induced constipation (OIC) in cancer patients. Poster presentation at: ASCO 2016 Annual Meeting; June 3-7, 2016; Chicago, IL.
2. Cleeland CS, Shi Q, Wang XS, et al. Minocycline to reduce chemoradiation-related fatigue in patients with non-small cell lung cancer: A phase II randomized trial. Poster presentation at: ASCO 2016 Annual Meeting; June 3-7, 2016; Chicago, IL.
3. Glimelius B, Manojlovic N, Pfeiffer P, et al. Persistent prevention of CIPN using calmangafodipir (PledOx): Results from a placebo-controlled randomized phase II study (PLIANT) in patients with metastatic colorectal cancer (mCRC). Poster presentation at: ASCO 2016 Annual Meeting; June 3-7, 2016; Chicago, IL.
4. Matsuzaki K, Ito Y, Fukuda M, et al. Placebo-controlled phase III study comparing dexamethasone on day 1 to on day 1-3 with NK1 receptor antagonist and palonosetron in high emetogenic chemotherapy. Poster presentation at: ASCO 2016 Annual Meeting; June 3-7, 2016; Chicago, IL.