PMID- 37060430 OWN - NLM STAT- MEDLINE DCOM- 20230519 LR - 20231213 IS - 1776-260X (Electronic) IS - 1776-2596 (Linking) VI - 18 IP - 3 DP - 2023 May TI - A Multicenter, Phase II Trial of Schedule Modification for Nab-Paclitaxel in Combination with Ramucirumab for Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer: The B-RAX Trial (JACCRO GC-09). PG - 359-368 LID - 10.1007/s11523-023-00961-x [doi] AB - BACKGROUND: This study investigated whether schedule modification of bi-weekly nanoparticle albumin-bound paclitaxel (nab-PTX) plus ramucirumab (RAM) is efficacious against gastric cancer (GC) or gastroesophageal junction cancer (GJC). PATIENTS AND METHODS: Patients with unresectable GC or GJC who were previously treated with fluoropyrimidine-containing regimens received nab-PTX (100 mg/m(2)) on days 1, 8, and 15 and RAM (8 mg/kg) on days 1 and 15 of a 28-day cycle. Based on the incidence of severe adverse events (AEs) during the first cycle, patients were modified to bi-weekly therapy from the second cycle. The primary endpoint was progression-free survival (PFS) in the bi-weekly therapy population. Based on the hypothesis that bi-weekly nab-PTX plus RAM would improve PFS from 4.5 to 7.0 months, 40 patients were required for power of 0.8 with a one-sided alpha of 0.05. RESULTS: Of the 81 patients enrolled, 47 patients (58%) were assigned to bi-weekly therapy. Patient characteristics were Eastern Cooperative Oncology Group performance status of 1 (19%) and diffuse type (45%). Median PFS was 4.7 months (95% confidence interval [CI] 3.7-5.6 months) and overall response rate was 25% (95% CI 11-39%). Severe AEs of grade 3 or worse were mainly neutropenia (83%) and hypertension (23%). EQ-5D scores were maintained during the treatment. In patients who continued standard-schedule therapy, median PFS was 2.7 months (95% CI 1.8-4.0 months). CONCLUSIONS: The primary endpoint for PFS was statistically not met, but modification of nab-PTX plus RAM to a bi-weekly schedule might be a feasible treatment option as second-line treatment for advanced GC/GJC patients, especially elderly patients, with severe AEs during the first cycle. CI - (c) 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG. FAU - Kawabata, Ryohei AU - Kawabata R AD - Department of Surgery, Osaka Rosai Hospital, Osaka, Japan. FAU - Izawa, Naoki AU - Izawa N AD - Department of Clinical Oncology, St. Marianna University School of Medicine, 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan. FAU - Suzuki, Takahisa AU - Suzuki T AD - Department of Surgery, National Hospital Organization Kure Medical Center, Kure, Japan. FAU - Nagahisa, Yoshio AU - Nagahisa Y AD - Department of Surgery, Kurashiki Central Hospital, Kurashiki, Japan. FAU - Nishikawa, Kazuhiro AU - Nishikawa K AD - Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan. FAU - Takahashi, Masazumi AU - Takahashi M AD - Division of Gastroenterological Surgery, Yokohama Municipal Citizen's Hospital, Yokohama, Japan. FAU - Nakamura, Masato AU - Nakamura M AD - Aizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan. FAU - Ishiguro, Atsushi AU - Ishiguro A AD - Department of Medical Oncology, Teine Keijinkai Hospital, Sapporo, Japan. FAU - Katsuya, Hiroo AU - Katsuya H AD - Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. FAU - Hihara, Jun AU - Hihara J AD - Department of Surgery, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan. FAU - Manaka, Dai AU - Manaka D AD - Department of Surgery, Gastro-Intestinal Center, Kyoto Katsura Hospital, Kyoto, Japan. FAU - Negoro, Yuji AU - Negoro Y AD - Department of Oncological Medicine, Kochi Health Sciences Center, Kochi, Japan. FAU - Tsuji, Akihito AU - Tsuji A AD - Department of Clinical Oncology, Faculty of Medicine, Kagawa University, Kagawa, Japan. FAU - Takahashi, Takao AU - Takahashi T AD - Department of Gastroenterological Surgery/Pediatric Surgery, Gifu University, Graduate School of Medicine, Gifu, Japan. FAU - Kochi, Mitsugu AU - Kochi M AD - Department of Gastrointestinal Surgery, International University of Health and Welfare Ichikawa Hospital, Ichikawa, Japan. FAU - Azuma, Mizutomo AU - Azuma M AD - Department of Gastroenterology, Kitasato University Hospital, Sagamihara, Japan. FAU - Kadowaki, Shigenori AU - Kadowaki S AD - Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. FAU - Michimae, Hirofumi AU - Michimae H AD - Department of Clinical Medicine (Biostatistics), School of Pharmacy, Kitasato University, Tokyo, Japan. FAU - Sunakawa, Yu AU - Sunakawa Y AUID- ORCID: 0000-0002-0163-7543 AD - Department of Clinical Oncology, St. Marianna University School of Medicine, 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan. y.sunakawa@marianna-u.ac.jp. FAU - Ichikawa, Wataru AU - Ichikawa W AD - Division of Medical Oncology, Showa University Fujigaoka Hospital, Yokohama, Japan. FAU - Fujii, Masashi AU - Fujii M AD - Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20230415 PL - France TA - Target Oncol JT - Targeted oncology JID - 101270595 RN - 0 (130-nm albumin-bound paclitaxel) RN - P88XT4IS4D (Paclitaxel) RN - 0 (RAX protein, human) RN - 0 (Eye Proteins) RN - 0 (Transcription Factors) RN - 0 (Homeodomain Proteins) SB - IM MH - Humans MH - Aged MH - *Stomach Neoplasms/drug therapy MH - Paclitaxel/pharmacology/therapeutic use MH - *Esophageal Neoplasms/drug therapy MH - Esophagogastric Junction MH - Antineoplastic Combined Chemotherapy Protocols/pharmacology/therapeutic use MH - Treatment Outcome MH - Eye Proteins/therapeutic use MH - Transcription Factors/therapeutic use MH - Homeodomain Proteins/therapeutic use MH - Ramucirumab EDAT- 2023/04/16 06:00 MHDA- 2023/05/19 06:42 CRDT- 2023/04/15 11:06 PHST- 2023/03/22 00:00 [accepted] PHST- 2023/05/19 06:42 [medline] PHST- 2023/04/16 06:00 [pubmed] PHST- 2023/04/15 11:06 [entrez] AID - 10.1007/s11523-023-00961-x [pii] AID - 10.1007/s11523-023-00961-x [doi] PST - ppublish SO - Target Oncol. 2023 May;18(3):359-368. doi: 10.1007/s11523-023-00961-x. Epub 2023 Apr 15.