{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T18:34:10Z","timestamp":1772822050351,"version":"3.50.1"},"reference-count":35,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2003,6,15]]},"abstract":"<jats:p> Purpose: Temozolomide (TMZ) and 13-cis-retinoic acid (cRA) have shown activity in prior single-agent trials of recurrent malignant gliomas (MG). This phase II trial evaluated efficacy and toxicity of combination temozolomide and cRA treatment in recurrent MG. <\/jats:p><jats:p> Patients and Methods: Adults with recurrent supratentorial MG for whom surgery, radiation, and\/or chemotherapy failed were eligible. Treatment included oral TMZ 150 or 200 mg\/m<jats:sup>2<\/jats:sup>\/d, days 1 through 5, and cRA 100 mg\/m<jats:sup>2<\/jats:sup>\/d, days 1 to 21, every 28 days. Primary end point was progression-free survival at 6 months (PFS 6); secondary end points included response, survival, and PFS12. <\/jats:p><jats:p> Results: Eighty-eight eligible patients (glioblastoma multiforme [n = 40]; anaplastic gliomas [n = 48; astrocytoma, 28; oligodendroglioma, 14; mixed glioma, six]) received treatment. PFS 6 was 43% (95% confidence interval [CI], 33% to 54%) and PFS12 was 16% (95% CI, 10% to 26%). Median overall PFS was 19 weeks (95% CI, 16 to 27 weeks), and median overall survival (OS) was 47 weeks (95% CI, 36 to 58 weeks). OS was 46% (95% CI, 36% to 57%) at 52 weeks and 21% (95% CI, 13% to 31%) at 104 weeks. Of 84 assessable patients, there were two (3%) complete responses and eight (12%) partial responses (complete plus partial response, 15%). Among 499 treatment cycles, the most common grade 3\/4 events included granulocytopenia (1.8%), thrombocytopenia (1.4%), and hypertriglyceridemia (1.2%). <\/jats:p><jats:p> Conclusion: TMZ and cRA were active, exceeding our 20% thresholds for PFS 6 success, assuming 20% improvement over our previously reported database (glioblastoma multiforme: expected, 30%; observed, 32%; anaplastic glioma: expected, 40%; observed, 50%). <\/jats:p>","DOI":"10.1200\/jco.2003.12.097","type":"journal-article","created":{"date-parts":[[2003,6,12]],"date-time":"2003-06-12T17:37:37Z","timestamp":1055439457000},"page":"2305-2311","source":"Crossref","is-referenced-by-count":121,"title":["Phase II Evaluation of Temozolomide and 13-cis-Retinoic Acid for the Treatment of Recurrent and Progressive Malignant Glioma: A North American Brain Tumor Consortium Study"],"prefix":"10.1200","volume":"21","author":[{"given":"Kurt A.","family":"Jaeckle","sequence":"first","affiliation":[{"name":"From the University of Texas M.D. Anderson Cancer Center, Houston; University of Texas Health Science Center, San Antonio; and University of Texas Southwestern Medical Center, Dallas, TX; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; University of Pittsburgh and Children\u2019s Hospital of Pittsburgh, Pittsburgh, PA; University of Wisconsin, Madison, WI; University of California at Los Angeles, Los Angeles; University of California at San Francisco, San Francisco, CA;..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenneth R.","family":"Hess","sequence":"additional","affiliation":[{"name":"From the University of Texas M.D. Anderson Cancer Center, Houston; University of Texas Health Science Center, San Antonio; and University of Texas Southwestern Medical Center, Dallas, TX; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; University of Pittsburgh and Children\u2019s Hospital of Pittsburgh, Pittsburgh, PA; University of Wisconsin, Madison, WI; University of California at Los Angeles, Los Angeles; University of California at San Francisco, San Francisco, CA;..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W.K. Alfred","family":"Yung","sequence":"additional","affiliation":[{"name":"From the University of Texas M.D. Anderson Cancer Center, Houston; University of Texas Health Science Center, San Antonio; and University of Texas Southwestern Medical Center, Dallas, TX; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; University of Pittsburgh and Children\u2019s Hospital of Pittsburgh, Pittsburgh, PA; University of Wisconsin, Madison, WI; University of California at Los Angeles, Los Angeles; University of California at San Francisco, San Francisco, CA;..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harry","family":"Greenberg","sequence":"additional","affiliation":[{"name":"From the University of Texas M.D. Anderson Cancer Center, Houston; University of Texas Health Science Center, San Antonio; and University of Texas Southwestern Medical Center, Dallas, TX; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; University of Pittsburgh and Children\u2019s Hospital of Pittsburgh, Pittsburgh, PA; University of Wisconsin, Madison, WI; University of California at Los Angeles, Los Angeles; University of California at San Francisco, San Francisco, CA;..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Howard","family":"Fine","sequence":"additional","affiliation":[{"name":"From the University of Texas M.D. Anderson Cancer Center, Houston; University of Texas Health Science Center, San Antonio; and University of Texas Southwestern Medical Center, Dallas, TX; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; University of Pittsburgh and Children\u2019s Hospital of Pittsburgh, Pittsburgh, PA; University of Wisconsin, Madison, WI; University of California at Los Angeles, Los Angeles; University of California at San Francisco, San Francisco, CA;..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Schiff","sequence":"additional","affiliation":[{"name":"From the University of Texas M.D. Anderson Cancer Center, Houston; University of Texas Health Science Center, San Antonio; and University of Texas Southwestern Medical Center, Dallas, TX; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; University of Pittsburgh and Children\u2019s Hospital of Pittsburgh, Pittsburgh, PA; University of Wisconsin, Madison, WI; University of California at Los Angeles, Los Angeles; University of California at San Francisco, San Francisco, CA;..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ian F.","family":"Pollack","sequence":"additional","affiliation":[{"name":"From the University of Texas M.D. Anderson Cancer Center, Houston; University of Texas Health Science Center, San Antonio; and University of Texas Southwestern Medical Center, Dallas, TX; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; University of Pittsburgh and Children\u2019s Hospital of Pittsburgh, Pittsburgh, PA; University of Wisconsin, Madison, WI; University of California at Los Angeles, Los Angeles; University of California at San Francisco, San Francisco, CA;..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Kuhn","sequence":"additional","affiliation":[{"name":"From the University of Texas M.D. Anderson Cancer Center, Houston; University of Texas Health Science Center, San Antonio; and University of Texas Southwestern Medical Center, Dallas, TX; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; University of Pittsburgh and Children\u2019s Hospital of Pittsburgh, Pittsburgh, PA; University of Wisconsin, Madison, WI; University of California at Los Angeles, Los Angeles; University of California at San Francisco, San Francisco, CA;..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"Fink","sequence":"additional","affiliation":[{"name":"From the University of Texas M.D. Anderson Cancer Center, Houston; University of Texas Health Science Center, San Antonio; and University of Texas Southwestern Medical Center, Dallas, TX; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; University of Pittsburgh and Children\u2019s Hospital of Pittsburgh, Pittsburgh, PA; University of Wisconsin, Madison, WI; University of California at Los Angeles, Los Angeles; University of California at San Francisco, San Francisco, CA;..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Minesh","family":"Mehta","sequence":"additional","affiliation":[{"name":"From the University of Texas M.D. Anderson Cancer Center, Houston; University of Texas Health Science Center, San Antonio; and University of Texas Southwestern Medical Center, Dallas, TX; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; University of Pittsburgh and Children\u2019s Hospital of Pittsburgh, Pittsburgh, PA; University of Wisconsin, Madison, WI; University of California at Los Angeles, Los Angeles; University of California at San Francisco, San Francisco, CA;..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timothy","family":"Cloughesy","sequence":"additional","affiliation":[{"name":"From the University of Texas M.D. Anderson Cancer Center, Houston; University of Texas Health Science Center, San Antonio; and University of Texas Southwestern Medical Center, Dallas, TX; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; University of Pittsburgh and Children\u2019s Hospital of Pittsburgh, Pittsburgh, PA; University of Wisconsin, Madison, WI; University of California at Los Angeles, Los Angeles; University of California at San Francisco, San Francisco, CA;..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. 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