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WJOG4207L

A multicenter phase II study of carboplatin and paclitaxel for advanced thymic carcinoma: WJOG4207L

Phase 2N = 40

Population
Chemotherapy-naive patients with advanced thymic carcinoma; 40 enrolled from 21 centres.
Design
Single-arm multicentre phase II study at 21 centres (West Japan Oncology Group), May 2008 to November 2010. Carboplatin (AUC 6) plus paclitaxel (200 mg/m2) every 3 weeks for a maximum of six cycles in chemotherapy-naive patients. Primary endpoint: objective response rate by independent review. Secondary endpoints: overall survival, progression-free survival and safety. SWOG two-stage design; planned sample size of 40 to reject an ORR of 20% under the expectation of 40% (power 0.85, type I error 0.05).
Primary endpoint
ORR
Arms
  • Carboplatin and paclitaxel (experimental, n = 40): Carboplatin AUC 6 plus paclitaxel 200 mg/m2 every 3 weeks for a maximum of six cycles
People
Hirai F, West Japan Oncology Group
Show the numbers
Results reported for WJOG4207L
EndpointAnalysisCarboplatin and paclitaxelControlEffect
ORR39 evaluable patients; 36 pathologically diagnosed by independent review, of whom 97% were thymic carcinomaprimaryHirai 201536% (21–53%)—P=0.031The abstract prints the responses as '1/13 complete/partial responses'. Grade 3-4 neutropenia occurred in 34 patients (87%); no treatment-related death.
PFS39 evaluable patientsprimaryHirai 2015median 7.5 months (6.2–12.3)—Median overall survival had not been reached (abstract).
Results reported for WJOG4207L
EndpointAnalysisCarboplatin and paclitaxelControlEffect
ORR39 evaluable patients; 36 pathologically diagnosed by independent review, of whom 97% were thymic carcinomaprimaryHirai 201536% (21–53%)—P=0.031The abstract prints the responses as '1/13 complete/partial responses'. Grade 3-4 neutropenia occurred in 34 patients (87%); no treatment-related death.
PFS39 evaluable patientsprimaryHirai 2015median 7.5 months (6.2–12.3)—Median overall survival had not been reached (abstract).
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Carboplatin and paclitaxel (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCarboplatin and paclitaxel
0100.0%
563.0%
943.5%
1427.4%
1917.3%
Primary publication: Hirai F, Yamanaka T, Taguchi K, Daga H, Ono A, Tanaka K, et al. A multicenter phase II study of carboplatin and paclitaxel for advanced thymic carcinoma: WJOG4207L. Ann Oncol. 2015;26(2):363-8. PubMedDOI

Appears in

Sources

  1. Hirai F, Yamanaka T, Taguchi K, Daga H, Ono A, Tanaka K, et al. A multicenter phase II study of carboplatin and paclitaxel for advanced thymic carcinoma: WJOG4207L. Ann Oncol. 2015;26(2):363-8.

    PubMedDOI