{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T01:56:30Z","timestamp":1791597390633,"version":"4.3.4"},"reference-count":19,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"34","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2006,12,1]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> For patients with small-cell lung cancer (SCLC), further chemotherapy is routinely considered at relapse after first-line therapy. However, proof of clinical benefit has not been documented. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> This study randomly assigned patients with relapsed SCLC not considered as candidates for standard intravenous therapy to best supportive care (BSC) alone (n = 70) or oral topotecan (2.3 mg\/m<jats:sup>2<\/jats:sup>\/d, days 1 through 5, every 21 days) plus BSC (topotecan; n = 71). <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> In the intent-to-treat population, survival (primary end point) was prolonged in the topotecan group (log-rank P = .0104). Median survival with BSC was 13.9 weeks (95% CI, 11.1 to 18.6) and with topotecan, 25.9 weeks (95% CI, 18.3 to 31.6). Statistical significance for survival was maintained in a subgroup of patients with a short treatment-free interval (\u2264 60 days). Response to topotecan was 7% partial and 44% stable disease. Patients on topotecan had slower quality of life deterioration and greater symptom control. Principal toxicities with topotecan were hematological: grade 4 neutropenia, 33%; grade 4 thrombocytopenia, 7%; and grade 3\/4 anemia, 25%. Comparing topotecan with BSC, infection \u2265 grade 2 was 14% versus 12% and sepsis 4% versus 1%; other grade 3\/4 events included vomiting 3% versus 0, diarrhea 6% versus 0, dyspnea 3% versus 9%, and pain 3% versus 6%. Toxic deaths occurred in four patients (6%) in the topotecan arm. All cause mortality within 30 days of random assignment was 13% on BSC and 7% on topotecan. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Chemotherapy with oral topotecan is associated with prolongation of survival and quality of life benefit in patients with relapsed SCLC. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2006.06.5821","type":"journal-article","created":{"date-parts":[[2006,11,30]],"date-time":"2006-11-30T01:03:34Z","timestamp":1164848614000},"page":"5441-5447","source":"Crossref","is-referenced-by-count":537,"title":["Phase III Trial Comparing Supportive Care Alone With Supportive Care With Oral Topotecan in Patients With Relapsed Small-Cell Lung Cancer"],"prefix":"10.1200","volume":"24","author":[{"given":"Mary E.R.","family":"O'Brien","sequence":"first","affiliation":[{"name":"From the Royal Marsden Hospital, Sutton; Christie Hospital, Manchester; GlaxoSmithKline, Harlow, United Kingdom; Institutul Oncologic, Cluj-Napoca, Romania; Active Treatment Hospital, Varna, Bulgaria; Lviv State Oncology, Lviv, Ukraine; Klinika za plu\u0107ne bolesti Jordanovac, Zagreb, Croatia; and Margit K\u00f3rh\u00e1z, Csorna, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tudor-Eliade","family":"Ciuleanu","sequence":"additional","affiliation":[{"name":"From the Royal Marsden Hospital, Sutton; Christie Hospital, Manchester; GlaxoSmithKline, Harlow, United Kingdom; Institutul Oncologic, Cluj-Napoca, Romania; Active Treatment Hospital, Varna, Bulgaria; Lviv State Oncology, Lviv, Ukraine; Klinika za plu\u0107ne bolesti Jordanovac, Zagreb, Croatia; and Margit K\u00f3rh\u00e1z, Csorna, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hristo","family":"Tsekov","sequence":"additional","affiliation":[{"name":"From the Royal Marsden Hospital, Sutton; Christie Hospital, Manchester; GlaxoSmithKline, Harlow, United Kingdom; Institutul Oncologic, Cluj-Napoca, Romania; Active Treatment Hospital, Varna, Bulgaria; Lviv State Oncology, Lviv, Ukraine; Klinika za plu\u0107ne bolesti Jordanovac, Zagreb, Croatia; and Margit K\u00f3rh\u00e1z, Csorna, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaroslav","family":"Shparyk","sequence":"additional","affiliation":[{"name":"From the Royal Marsden Hospital, Sutton; Christie Hospital, Manchester; GlaxoSmithKline, Harlow, United Kingdom; Institutul Oncologic, Cluj-Napoca, Romania; Active Treatment Hospital, Varna, Bulgaria; Lviv State Oncology, Lviv, Ukraine; Klinika za plu\u0107ne bolesti Jordanovac, Zagreb, Croatia; and Margit K\u00f3rh\u00e1z, Csorna, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Branka","family":"\u010cu\u010devi\u00e1","sequence":"additional","affiliation":[{"name":"From the Royal Marsden Hospital, Sutton; Christie Hospital, Manchester; GlaxoSmithKline, Harlow, United Kingdom; Institutul Oncologic, Cluj-Napoca, Romania; Active Treatment Hospital, Varna, Bulgaria; Lviv State Oncology, Lviv, Ukraine; Klinika za plu\u0107ne bolesti Jordanovac, Zagreb, Croatia; and Margit K\u00f3rh\u00e1z, Csorna, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabor","family":"Juhasz","sequence":"additional","affiliation":[{"name":"From the Royal Marsden Hospital, Sutton; Christie Hospital, Manchester; GlaxoSmithKline, Harlow, United Kingdom; Institutul Oncologic, Cluj-Napoca, Romania; Active Treatment Hospital, Varna, Bulgaria; Lviv State Oncology, Lviv, Ukraine; Klinika za plu\u0107ne bolesti Jordanovac, Zagreb, Croatia; and Margit K\u00f3rh\u00e1z, Csorna, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Thatcher","sequence":"additional","affiliation":[{"name":"From the Royal Marsden Hospital, Sutton; Christie Hospital, Manchester; GlaxoSmithKline, Harlow, United Kingdom; Institutul Oncologic, Cluj-Napoca, Romania; Active Treatment Hospital, Varna, Bulgaria; Lviv State Oncology, Lviv, Ukraine; Klinika za plu\u0107ne bolesti Jordanovac, Zagreb, Croatia; and Margit K\u00f3rh\u00e1z, Csorna, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham A.","family":"Ross","sequence":"additional","affiliation":[{"name":"From the Royal Marsden Hospital, Sutton; Christie Hospital, Manchester; GlaxoSmithKline, Harlow, United Kingdom; Institutul Oncologic, Cluj-Napoca, Romania; Active Treatment Hospital, Varna, Bulgaria; Lviv State Oncology, Lviv, Ukraine; Klinika za plu\u0107ne bolesti Jordanovac, Zagreb, Croatia; and Margit K\u00f3rh\u00e1z, Csorna, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham C.","family":"Dane","sequence":"additional","affiliation":[{"name":"From the Royal Marsden Hospital, Sutton; Christie Hospital, Manchester; GlaxoSmithKline, Harlow, United Kingdom; Institutul Oncologic, Cluj-Napoca, Romania; Active Treatment Hospital, Varna, Bulgaria; Lviv State Oncology, Lviv, Ukraine; Klinika za plu\u0107ne bolesti Jordanovac, Zagreb, Croatia; and Margit K\u00f3rh\u00e1z, Csorna, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theresa","family":"Crofts","sequence":"additional","affiliation":[{"name":"From the Royal Marsden Hospital, Sutton; Christie Hospital, Manchester; GlaxoSmithKline, Harlow, United Kingdom; 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