Journal of the National Cancer Institute · 2026
Randomized trial of adjuvant 5-FU-platinum vs paclitaxel-platinum for high-risk penile cancer.
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Noronha Vanita, Menon Nandini, Shah Minit, Patil Vijay, Dhanawat Aditya, Prakash Gagan, Pal Mahendra, Arora Amandeep, Misra Ankit, Goud Supriya, More Sucheta, Yadav Akanksha, Murthy Vedang, Maitre Priyamvada, Menon Santosh, Popat Palak, Sable Nilesh, Agarwal Archi, Rangarajan Venkatesh, Shetake Ankush, Badwe Rajendra, Prabhash Kumar
Аннотация
BACKGROUND: Adjuvant chemotherapy is recommended for high-risk penile squamous cell carcinoma (SCC) metastatic to lymph nodes based on retrospective data, but no randomized trials have been conducted. We compared 5-fluorouracil (5-FU)-platinum with paclitaxel-platinum in this setting.
METHODS: In this open-label, randomized trial at an Indian tertiary cancer center, men <70 years with resected node-positive penile SCC and ≥1 high-risk feature (perinodal extension, pelvic node involvement, >1 inguinal nodes, or ≥ 4 cm node) were assigned 1:1 to four 3-weekly cycles of 5-FU-platinum or paclitaxel-platinum, followed by cisplatin-based chemoradiotherapy. Primary endpoint was disease-free survival (DFS). Secondary endpoints were overall survival (OS), toxicity, and quality-of-life (QoL).
RESULTS: Between 2017 and 2024, 49 patients were randomized (5-FU-platinum: 25, paclitaxel-platinum: 24). At a median follow-up of 69 months, median DFS was 12.4 months (95% CI, 3.38-NR) vs 19.6 months (95% CI, 5.82-NR) (HR, 1.16; 95% CI, 0.55-2.45; P = 0.686) and median OS was 21.3 vs 36.7 months (HR, 1.13; 95% CI, 0.52-2.44; P = 0.754) for 5-FU-platinum and paclitaxel-platinum, respectively. Grade ≥3 toxicities occurred in 77.3% vs 40.9% (P = 0.014), grade ≥3 hematologic toxicities in 54.5% vs 4.5% (P < 0.001), and hospitalization for toxicity in 45.5% vs 9.1% (P = 0.016). Completion of all planned cycles was higher with paclitaxel-platinum (83.3% vs 48%; P = 0.009). QoL and sexual health were similar between the two treatment arms.
CONCLUSIONS: Adjuvant paclitaxel-platinum was associated with improved tolerability compared with fluorouracil-platinum in high-risk node positive penile cancer and warrants further evaluation in larger multicenter studies. Early termination precluded definitive efficacy comparisons.
TRIAL REGISTRATION: Clinical Trials Registry of India (CTRI/2016/12/007567).
FUNDING: This work was supported by Indian Cooperative Oncology Network and Tata Memorial Center.
METHODS: In this open-label, randomized trial at an Indian tertiary cancer center, men <70 years with resected node-positive penile SCC and ≥1 high-risk feature (perinodal extension, pelvic node involvement, >1 inguinal nodes, or ≥ 4 cm node) were assigned 1:1 to four 3-weekly cycles of 5-FU-platinum or paclitaxel-platinum, followed by cisplatin-based chemoradiotherapy. Primary endpoint was disease-free survival (DFS). Secondary endpoints were overall survival (OS), toxicity, and quality-of-life (QoL).
RESULTS: Between 2017 and 2024, 49 patients were randomized (5-FU-platinum: 25, paclitaxel-platinum: 24). At a median follow-up of 69 months, median DFS was 12.4 months (95% CI, 3.38-NR) vs 19.6 months (95% CI, 5.82-NR) (HR, 1.16; 95% CI, 0.55-2.45; P = 0.686) and median OS was 21.3 vs 36.7 months (HR, 1.13; 95% CI, 0.52-2.44; P = 0.754) for 5-FU-platinum and paclitaxel-platinum, respectively. Grade ≥3 toxicities occurred in 77.3% vs 40.9% (P = 0.014), grade ≥3 hematologic toxicities in 54.5% vs 4.5% (P < 0.001), and hospitalization for toxicity in 45.5% vs 9.1% (P = 0.016). Completion of all planned cycles was higher with paclitaxel-platinum (83.3% vs 48%; P = 0.009). QoL and sexual health were similar between the two treatment arms.
CONCLUSIONS: Adjuvant paclitaxel-platinum was associated with improved tolerability compared with fluorouracil-platinum in high-risk node positive penile cancer and warrants further evaluation in larger multicenter studies. Early termination precluded definitive efficacy comparisons.
TRIAL REGISTRATION: Clinical Trials Registry of India (CTRI/2016/12/007567).
FUNDING: This work was supported by Indian Cooperative Oncology Network and Tata Memorial Center.