JCOG 9606
A phase II trial of dose-dense chemotherapy, followed by surgical resection and/or thoracic radiotherapy, in locally advanced thymoma: report of a Japan Clinical Oncology Group trial (JCOG 9606)
Phase 2N = 23
- Population
- 23 patients entered (21 eligible) with previously untreated, histologically documented thymoma and unresectable stage III disease
- Design
- Single-arm phase II trial of the Japan Clinical Oncology Group (JCOG) in previously untreated, histologically documented thymoma with Masaoka stage III disease judged unresectable: 9 weeks of weekly dose-dense cisplatin-based chemotherapy, then surgery and postoperative radiotherapy, or radiotherapy alone if unresectable. 23 patients from eight institutions entered between July 1997 and April 2005 (two were ineligible, 21 eligible); the study was terminated because of slow accrual (30 eligible patients were planned). The primary end point was progression-free survival (full text); the secondary end points included toxicity, response, relapse pattern, OS and complete resection rate. 57% completed the planned 9 weeks; no toxic deaths; main toxicities neutropenia and anaemia. Of the 21 eligible patients, 13 had a thoracotomy (11 resected: 9 complete and 2 incomplete; 2 probe thoracotomies). Response, resection and survival are reported for the 21 eligible patients. The authors conclude the role of surgery remains unclear.
- Primary endpoint
- PFS
- Arms
- Dose-dense chemotherapy then resection and/or radiotherapy (experimental, n = 23): Cisplatin 25 mg/m2 on weeks 1-9; vincristine 1 mg/m2 on weeks 1, 2, 4, 6 and 8; doxorubicin 40 mg/m2 and etoposide 80 mg/m2 on days 1-3 of weeks 1, 3, 5, 7 and 9; then surgery and postoperative radiotherapy of 48 Gy, or radiotherapy of 60 Gy if unresectable
- People
- Kunitoh H, Japan Clinical Oncology Group (JCOG) Lung Cancer Study Group
Show the numbers
| Endpoint | Analysis | Dose-dense chemotherapy then resection and/or radiotherapy | Control | Effect |
|---|---|---|---|---|
| Partial response rate21 eligible patients (13 partial responses) | finalKunitoh 2010 | 62% (38–82%) | — | The abstract reports 13 partial responses among the 21 eligible patients and does not mention complete responses; the full text lists CR 0, PR 13, no change 7 and progression 1. |
| Complete resection rate21 eligible patients (nine R0 resections) | finalKunitoh 2010 | 43% | — | The abstract prints nine complete resections as 39% (9 of 23 entered); the Results section gives 43% of the 21 eligible patients. Both are published; the eligible-patient denominator matches the other analyses and is shown here. |
| PFS21 eligible patients | finalKunitoh 2010 | 80% at 2 y; 43% at 5 y (21–63%); 32% at 8 y | — | Median PFS 4.5 years (95% CI 2.3 to not calculable). Survival data last updated May 2009. |
| OS21 eligible patients | finalKunitoh 2010 | 85% at 5 y (61–95%); 69% at 8 y | — | Median OS not reached; OS 100% at 2 years. The abstract states that survival did not seem to be affected by resection; in the full text the 21 eligible patients are split by resection (11 resected, 10 not) with no significant difference (log-rank P = 0.59 for OS, P = 0.75 for PFS). |
| Endpoint | Analysis | Dose-dense chemotherapy then resection and/or radiotherapy | Control | Effect |
|---|---|---|---|---|
| Partial response rate21 eligible patients (13 partial responses) | finalKunitoh 2010 | 62% (38–82%) | — | The abstract reports 13 partial responses among the 21 eligible patients and does not mention complete responses; the full text lists CR 0, PR 13, no change 7 and progression 1. |
| Complete resection rate21 eligible patients (nine R0 resections) | finalKunitoh 2010 | 43% | — | The abstract prints nine complete resections as 39% (9 of 23 entered); the Results section gives 43% of the 21 eligible patients. Both are published; the eligible-patient denominator matches the other analyses and is shown here. |
| PFS21 eligible patients | finalKunitoh 2010 | 80% at 2 y; 43% at 5 y (21–63%); 32% at 8 y | — | Median PFS 4.5 years (95% CI 2.3 to not calculable). Survival data last updated May 2009. |
| OS21 eligible patients | finalKunitoh 2010 | 85% at 5 y (61–95%); 69% at 8 y | — | Median OS not reached; OS 100% at 2 years. The abstract states that survival did not seem to be affected by resection; in the full text the 21 eligible patients are split by resection (11 resected, 10 not) with no significant difference (log-rank P = 0.59 for OS, P = 0.75 for PFS). |
- Dose-dense chemotherapy then resection and/or radiotherapy (experimental)
Data table (modelled values)
| Months | Dose-dense chemotherapy then resection and/or radiotherapy |
|---|---|
| 0 | 100.0% |
| 26 | 78.1% |
| 52 | 49.6% |
| 78 | 35.9% |
| 104 | 32.0% |
- Dose-dense chemotherapy then resection and/or radiotherapy (experimental)
Data table (modelled values)
| Months | Dose-dense chemotherapy then resection and/or radiotherapy |
|---|---|
| 0 | 100.0% |
| 26 | 94.1% |
| 52 | 87.6% |
| 78 | 77.4% |
| 104 | 69.0% |
Appears in
Sources
Kunitoh H, Tamura T, Shibata T, Takeda K, Katakami N, Nakagawa K, et al. A phase II trial of dose-dense chemotherapy, followed by surgical resection and/or thoracic radiotherapy, in locally advanced thymoma: report of a Japan Clinical Oncology Group trial (JCOG 9606). Br J Cancer. 2010;103(1):6-11.