Table 2.
Overall response
| Rilotumumab plus epirubicin, cisplatin, and capecitabine (n=262) |
Placebo plus epirubicin, cisplatin, and capecitabine n=267) |
|
|---|---|---|
| Best overall response* | ||
| Complete response | 3 (1%) | 8 (3%) |
| Partial response | 75 (29%) | 111 (42%) |
| Stable disease† | 62 (24%) | 70 (26%) |
| Progressive disease | 42 (16%) | 37 (14%) |
| Non-complete response or non-progressive disease‡ | 1 (<1%) | 0 |
| Not evaluable | 8 (3%) | 8 (3%) |
| Missing§ | 71 (27%) | 33 (12%) |
| Objective response (95% CI)¶ | 29·8% (24·3–35·7) | 44·6% (38·5–50·8) |
| Stratified odds ratio (95% CI) | 0·53 (0·37–0·76) | ·· |
| p value | 0·0005 | ·· |
| Disease control (95% CI)‖ | 53·4% (47·2–59·6) | 70·8% (64·9–76·2) |
| Stratified odds ratio (95% CI) | 0·47 (0·33–0·68) | ·· |
| p value | <0·0001 | ·· |
Data are n (%) unless otherwise stated. Response analysis set includes all patients with at least one unidimensionally measurable lesion at baseline per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Defined as best observed disease response per RECIST 1.1, excluding tumour assessments after initiation of new anticancer therapy, surgical resection, or an assessment of disease progression.
Classification required patients to have stable disease at least 11 weeks after the first dose of protocol-specified therapy.
Non-complete response or non-progressive disease was defined as measurable disease without target lesions at baseline and no new lesions developed during therapy.
The first scan after baseline was scheduled to occur at week 12±7 days. Of the 104 patients with missing response results, 58 ended the study before the first scan was expected (death, n=43; consent withdrawal, n=12; other, n=3). An additional seven patients (rilotumumab, n=4; placebo, n=3) ended the study during the scan window but before the scan occurred (death, n=5 [rilotumumab, n=3; placebo, n=2]; lost to follow-up, n=1 [rilotumumab]; consent withdrawal, n=1 [placebo]), and 39 patients remained on study but missed the scan window (rilotumumab, n=24; placebo, n=15).
Objective response defined as complete response plus partial response.
Disease control defined as complete response plus partial response plus stable disease.