{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T22:23:21Z","timestamp":1790461401236,"version":"4.1.0"},"reference-count":16,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2011,7,26]],"date-time":"2011-07-26T00:00:00Z","timestamp":1311638400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2011,7,26]],"date-time":"2011-07-26T00:00:00Z","timestamp":1311638400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2012,2,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>Refractory germ cell tumor (GCT) patients have a poor prognosis and limited treatment options. The identification of novel active agents may be impaired by use of response as the primary endpoint in phase 2 trials. Improved endpoints could enhance the development of new effective agents.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>The characteristics and outcome of refractory GCT patients enrolled in 7 single\u2010agent phase 2 trials conducted at Memorial Sloan\u2010Kettering Cancer Center from 1990 to 2008 were reviewed. The study agents were suramin, all\u2010transretinoic acid, topotecan, pyrazoloacridine, temozolomide, ixabepilone, and sunitinib. The major endpoints evaluated were response, progression\u2010free survival (PFS), and overall survival (OS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>Ninety patients (87 male, 3 female) were treated. The primary tumor site was testis in 65 patients, mediastinum in 17 patients, retroperitoneum in 4 patients, and other in 4 patients. Eighty\u2010six patients had nonseminoma, and 4 patients had pure seminoma. Best responses were 1 (1%) partial response (ixabepilone), 15 (17%) stable disease, and 74 (82%) progressive disease. Median PFS and OS were 1.0 month (95% confidence interval [CI], 0.8\u20101.3) and 4.7 months (95% CI, 3.5\u20106.4), respectively. Eighty\u2010six of the 90 patients have died. The 12\u2010 and 16\u2010week PFS rates were 9% (95% CI, 3\u201015%) and 6% (95% CI, 1%\u201011%), respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>Patients with refractory GCT progressed rapidly to these single agents. PFS and OS may be useful endpoints for designing phase 2 trials testing novel agents in this population. Twelve\u2010week PFS (with comparison to the 9% benchmark rate reported herein) is the recommended endpoint for phase 2 trial design and median OS (using 4.7 months as the predicted median for the control arm) is suggested for phase 3 trials. Cancer 2012;. \u00a9 2011 American Cancer Society.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cncr.26375","type":"journal-article","created":{"date-parts":[[2011,7,26]],"date-time":"2011-07-26T12:05:47Z","timestamp":1311681947000},"page":"981-986","source":"Crossref","is-referenced-by-count":62,"title":["Progression\u2010free and overall survival in patients with relapsed\/refractory germ cell tumors treated with single\u2010agent chemotherapy: Endpoints for clinical trial design"],"prefix":"10.1002","volume":"118","author":[{"given":"Darren R.","family":"Feldman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sujata","family":"Patil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Trinos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryann","family":"Carousso","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle S.","family":"Ginsberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Sheinfeld","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dean F.","family":"Bajorin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George J.","family":"Bosl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert J.","family":"Motzer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,7,26]]},"reference":[{"key":"e_1_2_7_2_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.299.6.672"},{"key":"e_1_2_7_3_2","unstructured":"National Cancer Institute. SEER cancer statistics review 1975\u20132004. Average years of life lost per person dying of cancer all races both sexes 2006. Available at:http:\/\/seer. cancer.gov\/csr\/1975_2004\/results_figure\/sect_01_zfig.19.pdf. 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