October 10, 2024:

A Big Ten Cancer Research Consortium (Big Ten CRC) study, BTCRC-GI15-015, led by Al B. Benson III, MD, of Northwestern University, was published in The Oncologist on September 18, 2024. The article is titled, “A phase II study of FOLFOX combined with nab-paclitaxel in the treatment of metastatic or advanced unresectable gastric, gastroesophageal junction adenocarcinoma: a Big Ten Cancer Research Consortium trial.”

Congratulations to all co-authors and study teams whose hard work led to this publication.

Abstract:

Doublet platinum or taxane-based therapies are the current standard backbone of treatment for advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Previously used anthracycline-based triplet regimens are no longer used routinely due to toxicity and lack of superior efficacy. We hypothesized that the addition of nab-paclitaxel to FOLFOX (FOLFOX-A) would induce higher efficacy and better tolerability.

Eligible patients with chemotherapy-naïve advanced unresectable HER2-negative gastric or GEJ adenocarcinoma were enrolled in this phase II single-arm trial of FOLFOX (oxaliplatin 85 mg/m², leucovorin 400 mg/m², 5-FU 2400 mg/m² over 46-48 hours) + nab-paclitaxel (150 mg/m²) every 14 days of a 28-day cycle. Evaluable disease according to RECIST v1.1 for solid tumors was required. The primary endpoint was the objective response rate. Simon’s optimal 2-stage design was used to test 5% versus 20% response rate with 90% power and 10% one-sided type I error rate.

The study enrolled 39 patients. Median age was 63 (range 20-80) years, 30 (77%) were male, 34 (94%) were White, and 21 (57%) had gastric tumors. The median number of cycles completed was 4.5 (range: 0-36), and 25 patients required dose reductions or discontinuation of at least one component due to toxicity. Of the 38 patients evaluable for response, 15 (42.9%) had complete/partial response (CR/PR) as the best response, and 13 (37.1%) had stable disease. progression-free survival (PFS) and OS data were available for 38 patients, with a median follow-up duration of 27 months (range: 18.2-51.9 months for censored patients). Median PFS was 6.6 months (95% CI: 5.6-12.9), with 31.0% (95% CI: 18.4%-52.4%) 12-month PFS rate. The median OS was 10.5 months (95% CI: 8.8-20.7), 12-month OS rate was 44.7% (95% CI: 31.4%-63.7%). Treatment-related grade 3-4 toxicities included peripheral sensory neuropathy and anemia (18.4% each), neutropenia (15.8%), and diarrhea and lymphopenia (7.9% each).

FOLFOX-A has a significant response rate,

expected toxicities, and should be considered for future investigation in combination with immunotherapy given the recent approvals.

Read the full article.

Authors:

Marie S Dreyer (Robert H. Lurie Comprehensive Cancer Center, Northwestern University), Mary Mulcahy (Robert H. Lurie Comprehensive Cancer Center, Northwestern University), Masha Kocherginsky (Feinberg School of Medicine, Northwestern University), Yolande Chen (University of Illinois at Chicago), Howard S Hochster (Rutgers Cancer Institute of New Jersey), Pashtoon M Kasi (University of Iowa), Sheetal Kircher (Robert H. Lurie Comprehensive Cancer Center, Northwestern University), Emil Lou (University of Minnesota School of Medicine), Yangruijue Ma (Feinberg School of Medicine, Northwestern University), Nataliya V Uboha (University of Wisconsin Carbone Cancer Center), Al B Benson, III (Robert H. Lurie Comprehensive Cancer Center, Northwestern University)

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative clinical trials and observational studies that seek to improve the lives of cancer patients in the diverse communities we serve by leveraging the scientific and clinical expertise of Big Ten universities. The Big Ten Cancer Research Consortium creates a unique team research culture to drive science rapidly from ideas to treatment and prevention. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow. Since its founding, the Big Ten CRC has activated nearly 40 clinical trials across a wide range of cancer types, more than 1,000 participants have enrolled in Big Ten CRC studies, and more than 500 researchers have joined Big Ten CRC Clinical Trial Working Groups.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 18 Big Ten institutions provide direct financial support for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women. For more information, visit www.bigten.org.