Studies included in pooled analysis and outcomes. Description of study schema
| Study Name Ref. / Particular Characteristics . | Treatment Arm . | Survival . | n . | Interval Diagnosis to Post Cycle 6 † . | # Patients (%) Progression Free Post Cycle 6 . | # Patients Included in the Analysis . | |
|---|---|---|---|---|---|---|---|
| 6 cy . | >6 cy . | ||||||
| EORTC 26981/ NCIC CE3 [ref. 1, 8] | RT→vs | HR 0.63 (95% CI: 0.52–0.75), P < .001 | 286 | N/A | N/A | NA | |
| TMZ/RT→TMZ | 287* | Median 9.4 mo (IQR: 9.1–9.8) | 92/287 (32) | 92 | 0 | ||
| EORTC 26071-CENTRIC. Methylated tumors [3] | TMZ/RT → TMZ vs | No difference, HR 1.01 | 273 | Median 9.1 mo (IQR: 8.9–9.3) | 108/273 (40) | 77 | 31 |
| Cil + TMZ/RT→TMZ | 272 | 115/272 (42) | 96 | 19 | |||
| EMD-CORE. Unmethylated tumors [5] | TMZ/RT →TMZ vs | Randomized phase II trial. Overall comparable outcome | 89 | Median 9.1 mo (IQR: 8.9–9.3) | 15/89 (17) | 13 | 2 |
| Cil (2d/wk/) TMZ/ RT→TMZ | 88 | 23/88 (26) | 18 | 5 | |||
| Cil (5d/wk/) TMZ/ RT→TMZ | 88 | 28/88 (32) | 22 | 6 | |||
| RTOG 0525/ EORTC 26052 [7] | TMZ/RT → TMZ | No difference, HR 1.03 | 411 | Median 9.0 mo (IQR: 8.7–9.3) | 115/411 (28) | 5 | 110 |
| TMZ/RT → dd TMZ | 420 | 128/420 (30) | 10 | 118 | |||
| Total number of patients enrolled | 2214 | Median 9.1 mo (IQR: 8.8–9.4) | 624/1928 (32) | 333 | 291 | ||
| Study Name Ref. / Particular Characteristics . | Treatment Arm . | Survival . | n . | Interval Diagnosis to Post Cycle 6 † . | # Patients (%) Progression Free Post Cycle 6 . | # Patients Included in the Analysis . | |
|---|---|---|---|---|---|---|---|
| 6 cy . | >6 cy . | ||||||
| EORTC 26981/ NCIC CE3 [ref. 1, 8] | RT→vs | HR 0.63 (95% CI: 0.52–0.75), P < .001 | 286 | N/A | N/A | NA | |
| TMZ/RT→TMZ | 287* | Median 9.4 mo (IQR: 9.1–9.8) | 92/287 (32) | 92 | 0 | ||
| EORTC 26071-CENTRIC. Methylated tumors [3] | TMZ/RT → TMZ vs | No difference, HR 1.01 | 273 | Median 9.1 mo (IQR: 8.9–9.3) | 108/273 (40) | 77 | 31 |
| Cil + TMZ/RT→TMZ | 272 | 115/272 (42) | 96 | 19 | |||
| EMD-CORE. Unmethylated tumors [5] | TMZ/RT →TMZ vs | Randomized phase II trial. Overall comparable outcome | 89 | Median 9.1 mo (IQR: 8.9–9.3) | 15/89 (17) | 13 | 2 |
| Cil (2d/wk/) TMZ/ RT→TMZ | 88 | 23/88 (26) | 18 | 5 | |||
| Cil (5d/wk/) TMZ/ RT→TMZ | 88 | 28/88 (32) | 22 | 6 | |||
| RTOG 0525/ EORTC 26052 [7] | TMZ/RT → TMZ | No difference, HR 1.03 | 411 | Median 9.0 mo (IQR: 8.7–9.3) | 115/411 (28) | 5 | 110 |
| TMZ/RT → dd TMZ | 420 | 128/420 (30) | 10 | 118 | |||
| Total number of patients enrolled | 2214 | Median 9.1 mo (IQR: 8.8–9.4) | 624/1928 (32) | 333 | 291 | ||
Abbreviations: Cil, cilengitide; d, day; dd, dose-dense; IQR: Q1-Q3 interquartile range.
* Only the TMZ/RT->TMZ arm was used for pooled data. Both TMZ/RT->TMZ and experimental arms were used for the other 3 trials to maximize the sample size for the analyses, since none of the experimental arms demonstrated significant benefit over TMZ/RT->TMZ.
† Interval diagnosis—post cycle 6: Time interval from initial histological diagnosis (surgery date) until inclusion in current analysis (=day 1 of cycle 6 + 28 days).
Studies included in pooled analysis and outcomes. Description of study schema
| Study Name Ref. / Particular Characteristics . | Treatment Arm . | Survival . | n . | Interval Diagnosis to Post Cycle 6 † . | # Patients (%) Progression Free Post Cycle 6 . | # Patients Included in the Analysis . | |
|---|---|---|---|---|---|---|---|
| 6 cy . | >6 cy . | ||||||
| EORTC 26981/ NCIC CE3 [ref. 1, 8] | RT→vs | HR 0.63 (95% CI: 0.52–0.75), P < .001 | 286 | N/A | N/A | NA | |
| TMZ/RT→TMZ | 287* | Median 9.4 mo (IQR: 9.1–9.8) | 92/287 (32) | 92 | 0 | ||
| EORTC 26071-CENTRIC. Methylated tumors [3] | TMZ/RT → TMZ vs | No difference, HR 1.01 | 273 | Median 9.1 mo (IQR: 8.9–9.3) | 108/273 (40) | 77 | 31 |
| Cil + TMZ/RT→TMZ | 272 | 115/272 (42) | 96 | 19 | |||
| EMD-CORE. Unmethylated tumors [5] | TMZ/RT →TMZ vs | Randomized phase II trial. Overall comparable outcome | 89 | Median 9.1 mo (IQR: 8.9–9.3) | 15/89 (17) | 13 | 2 |
| Cil (2d/wk/) TMZ/ RT→TMZ | 88 | 23/88 (26) | 18 | 5 | |||
| Cil (5d/wk/) TMZ/ RT→TMZ | 88 | 28/88 (32) | 22 | 6 | |||
| RTOG 0525/ EORTC 26052 [7] | TMZ/RT → TMZ | No difference, HR 1.03 | 411 | Median 9.0 mo (IQR: 8.7–9.3) | 115/411 (28) | 5 | 110 |
| TMZ/RT → dd TMZ | 420 | 128/420 (30) | 10 | 118 | |||
| Total number of patients enrolled | 2214 | Median 9.1 mo (IQR: 8.8–9.4) | 624/1928 (32) | 333 | 291 | ||
| Study Name Ref. / Particular Characteristics . | Treatment Arm . | Survival . | n . | Interval Diagnosis to Post Cycle 6 † . | # Patients (%) Progression Free Post Cycle 6 . | # Patients Included in the Analysis . | |
|---|---|---|---|---|---|---|---|
| 6 cy . | >6 cy . | ||||||
| EORTC 26981/ NCIC CE3 [ref. 1, 8] | RT→vs | HR 0.63 (95% CI: 0.52–0.75), P < .001 | 286 | N/A | N/A | NA | |
| TMZ/RT→TMZ | 287* | Median 9.4 mo (IQR: 9.1–9.8) | 92/287 (32) | 92 | 0 | ||
| EORTC 26071-CENTRIC. Methylated tumors [3] | TMZ/RT → TMZ vs | No difference, HR 1.01 | 273 | Median 9.1 mo (IQR: 8.9–9.3) | 108/273 (40) | 77 | 31 |
| Cil + TMZ/RT→TMZ | 272 | 115/272 (42) | 96 | 19 | |||
| EMD-CORE. Unmethylated tumors [5] | TMZ/RT →TMZ vs | Randomized phase II trial. Overall comparable outcome | 89 | Median 9.1 mo (IQR: 8.9–9.3) | 15/89 (17) | 13 | 2 |
| Cil (2d/wk/) TMZ/ RT→TMZ | 88 | 23/88 (26) | 18 | 5 | |||
| Cil (5d/wk/) TMZ/ RT→TMZ | 88 | 28/88 (32) | 22 | 6 | |||
| RTOG 0525/ EORTC 26052 [7] | TMZ/RT → TMZ | No difference, HR 1.03 | 411 | Median 9.0 mo (IQR: 8.7–9.3) | 115/411 (28) | 5 | 110 |
| TMZ/RT → dd TMZ | 420 | 128/420 (30) | 10 | 118 | |||
| Total number of patients enrolled | 2214 | Median 9.1 mo (IQR: 8.8–9.4) | 624/1928 (32) | 333 | 291 | ||
Abbreviations: Cil, cilengitide; d, day; dd, dose-dense; IQR: Q1-Q3 interquartile range.
* Only the TMZ/RT->TMZ arm was used for pooled data. Both TMZ/RT->TMZ and experimental arms were used for the other 3 trials to maximize the sample size for the analyses, since none of the experimental arms demonstrated significant benefit over TMZ/RT->TMZ.
† Interval diagnosis—post cycle 6: Time interval from initial histological diagnosis (surgery date) until inclusion in current analysis (=day 1 of cycle 6 + 28 days).
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