A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer

• Published in: International journal of clinical oncology 2019-12, Vol.24 (12), p.1574-1581
• Main Authors: Hasegawa, Rikiya, Okuwaki, Kosuke, Kida, Mitsuhiro, Yamauchi, Hiroshi, Kawaguchi, Yusuke, Matsumoto, Takaaki, Kaneko, Toru, Miyata, Eiji, Uehara, Kazuho, Iwai, Tomohisa, Watanabe, Masafumi, Kurosu, Takahiro, Imaizumi, Hiroshi, Ohno, Takashi, Koizumi, Wasaburo
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Albumins - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Body fat; Cancer Research; Cancer therapies; Chemotherapy; Clinical trials; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Disease control; Dosage; Feasibility Studies; Female; Gemcitabine; Geriatrics; Hematologic Diseases - chemically induced; Humans; Male; Medicine; Medicine & Public Health; Nanoparticles; Oncology; Original Article; Paclitaxel; Paclitaxel - administration & dosage; Pancreatic cancer; Pancreatic Neoplasms - drug therapy; Pancreatic Neoplasms - mortality; Pancreatic Neoplasms - surgery; Patients; Peripheral nerves; Peripheral Nervous System Diseases - chemically induced; Prospective Studies; Surgical Oncology; Survival; Treatment Outcome
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-019-01511-0

Background The efficacy and safety of nanoparticle albumin-bound paclitaxel ( nab -PTX) plus gemcitabine (GEM) in elderly Japanese patients with pancreatic cancer remain unclear. Therefore, we prospectively investigated the tolerability and efficacy of nab -PTX + GEM in Japanese patients aged ≥ 75 years with non-curatively resectable pancreatic cancer. Methods We treated eligible patients ( n  = 27) with nab -PTX + GEM until disease progression, appearance of adverse events, or withdrawal of consent. The primary endpoints included adverse events as well as dosing- and survival-related parameters. Results The rates of 2-cycle completion were 48.1% for nab -PTX and 55.6% for GEM; the relative dose intensities for the 7th (median) treatment cycle were 65.1% and 74.1%, respectively, whereas the dose-reduction rates were 81.5% and 48.1%, respectively. Grade 3 or higher hemotoxicity was observed in 14 of 27 subjects (51.9%); moreover, 22% experienced grade ≥ 3 peripheral nerve disorder and 1 patient (3.7%) died owing to chemotherapy-related interstitial pneumonia. The disease control rate was 92.6% (25/27), while the median progression-free and overall survival times were 7 and 10.3 months, respectively. Conclusion The nab -PTX + GEM regimen is as efficacious in elderly patients who meet certain criteria as it is in previously reported non-elderly patients. The regimen is feasible with appropriate dose adjustments and attention to adverse events. Trial registration Clinical trial registration number: UMIN000018907.