{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T18:06:28Z","timestamp":1790273188202,"version":"4.1.0"},"reference-count":23,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T00:00:00Z","timestamp":1787529600000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Indian Cooperative Oncology Network and Tata Memorial Center"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this open-label, randomized trial at an Indian tertiary cancer center, men &amp;lt;70\u2009years with resected node-positive penile SCC and \u22651 high-risk feature (perinodal extension, pelvic node involvement, &amp;gt;1 inguinal nodes, or \u22654\u2009cm 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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Between 2017 and 2024, 49 patients were randomized (5-FU-platinum: 25, paclitaxel-platinum: 24). At a median follow-up of 69\u2009months, median DFS was 12.4\u2009months (95% CI = 3.38 to not reached [NR]) vs 19.6\u2009months (95% CI = 5.82 to NR) (HR = 1.16; 95% CI = 0.55 to 2.45; P\u2009=\u2009.686), and median OS was 21.3 vs 36.7\u2009months (HR = 1.13; 95% CI = 0.52 to 2.44; P\u2009=\u2009.754) for 5-FU-platinum and paclitaxel-platinum, respectively. Grade \u22653 toxicities occurred in 77.3% vs 40.9% (P\u2009=\u2009.014), grade \u22653 hematologic toxicities in 54.5% vs 4.5% (P\u2009&amp;lt;\u2009.001), and hospitalization for toxicity in 45.5% vs 9.1% (P\u2009=\u2009.016). Completion of all planned cycles was higher with paclitaxel-platinum (83.3% vs 48%; P\u2009=\u2009.009). QoL and sexual health were similar between the 2 treatment arms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>Clinical Trials Registry of India (CTRI\/2016\/12\/007567).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jnci\/djag288","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T11:45:10Z","timestamp":1787226310000},"source":"Crossref","is-referenced-by-count":0,"title":["Randomized trial of adjuvant 5-FU-platinum versus paclitaxel-platinum for high-risk penile cancer"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0191-2744","authenticated-orcid":false,"given":"Vanita","family":"Noronha","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute , Navi Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nandini","family":"Menon","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute , Navi Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Minit","family":"Shah","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute , Navi Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6168-363X","authenticated-orcid":false,"given":"Vijay","family":"Patil","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hinduja Hospital and Medical Research Centre , Navi Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aditya","family":"Dhanawat","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Tata Memorial Hospital, and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute , Navi Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gagan","family":"Prakash","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute , Navi Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahendra","family":"Pal","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute , Navi Mumbai, 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Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sucheta","family":"More","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute , Navi Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akanksha","family":"Yadav","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute , Navi Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vedang","family":"Murthy","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Tata Memorial Hospital, Homi Bhabha National Institute , Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Priyamvada","family":"Maitre","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Tata Memorial Hospital, and Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Homi Bhabha National Institute , Navi Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Santosh","family":"Menon","sequence":"additional","affiliation":[{"name":"Department of Pathology, Tata Memorial Hospital, Homi Bhabha National Institute , Navi Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Palak","family":"Popat","sequence":"additional","affiliation":[{"name":"Department of Radiology, Tata Memorial Hospital, Homi Bhabha National Institute , Navi Mumbai, Maharashtra,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nilesh","family":"Sable","sequence":"additional","affiliation":[{"name":"Department of Radiodiagnosis, Tata Memorial Hospital, Homi Bhabha National Institute , Navi Mumbai, 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