KEY TAKEAWAYS
- The PRODIGY phase III trial aimed to report the long-term outcomes, including OS.
- The primary endpoint was PFS, while the secondary endpoint was OS.
- The study found neoadjuvant DOS chemotherapy prolongs survival in locally advanced gastric cancer Asian pts.
Neoadjuvant docetaxel, oxaliplatin, and S-1(DOS) chemotherapy delayed cancer progression, leading to longer survival in locally advanced gastric cancer patients(pts). Researchers aimed to report the long-term outcomes, including overall survival (OS).
The study recruited pts with histologically confirmed primary gastric or gastroesophageal junction adenocarcinoma, specifically those with clinical T2-3N+ or T4Nany disease, from 18 Korean study sites. Pts were randomly divided into 2 groups, one receiving D2 surgery encountered by adjuvant S-1 (40–60 mg orally twice a day, days 1–28 q6w for eight cycles; SC group) and the other receiving neoadjuvant DOS (docetaxel 50 mg/m2, oxaliplatin 100 mg/m2 intravenously day 1, S-1 40 mg/m2 orally twice a day, days 1–14 q3w for three cycles) before D2 surgery, followed by adjuvant S-1 (CSC group). The primary endpoint was progression-free survival (PFS), and overall survival (OS) was secondary. This analysis provides the final assessment of outcomes after 5 years.
About 266 and 264 pts were randomly assigned to the CSC and SC arms, with 238 and 246 pts treated and included in the full analysis set. As of the data cut-off in September 2022, surviving pts had a median follow-up duration of 99.5 months (range, 68.6–127.7 months). CSC showed a significant increase in overall survival (OS) compared to SC, with a 5-year OS rate of 66.8% for CSC and 63.0% for SC. The hazard ratio was 0.72 (adjusted hazard ratio, 0.72; 95% CI, 0.54 to 0.97; stratified log-rank P=0.028). CSC significantly improved progression-free survival (PFS) with a 5-year PFS rate of 60.6% for CSC and 56.9% for SC, with a hazard ratio of 0.71 (adjusted hazard ratio, 0.71; 95% CI, 0.53 to 0.94; stratified log-rank P=0.019).
The study found neoadjuvant DOS chemotherapy prolongs survival in locally advanced gastric cancer Asian pts and warrants further investigation as a potential standard treatment option.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.4067
Clinical Trial: https://www.clinicaltrials.gov/study/NCT01515748
Yoon-Koo Kang, Hyung-Don Kim, Jeong Hwan Yook, Young-Kyu Park, Young-Woo Kim, Jin Young Kim, Min-Hee Ryu, Sun Young Rha, Ik-Joo Chung, In-Ho Kim, Sang Cheul Oh, Chang Hak Yoo, Seok Yun Kang, Dae Young Zang, Sunju Kim, and Sung Hoon Noh. DOI: 10.1200/JCO.2023.41.16_suppl.4067 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 4067-4067.
