Table 2.
Summary of efficacy endpoints (intent-to-treat population)
| Investigator assessment | |||
|---|---|---|---|
| Endpoint | R-CHOP (N = 710) | G-CHOP (N = 704) | |
| Median observation time (range), months | 47.4 (0.1–78.2) | 48.0 (0.1–76.5) | |
| Investigator-assessed PFS (primary endpoint) | |||
| Patients with event, n (%) | 233 (32.8) | 224 (31.8) | |
| 5-year PFS, % (95% CI) | 62.6 (58.1–66.8) | 63.8 (59.3–68.0) | |
| Stratified HR (95% CI) | 0.94 (0.78–1.12) | ||
| P (log-rank)* | P = 0.48 | ||
| OS | |||
| Patients with event, n (%) | 145 (20.4) | 149 (21.2) | |
| 5-year OS, % (95% CI) | 77.7 (74.1–80.9) | 77.0 (73.3–80.3) | |
| Stratified HR (95% CI) | 1.02 (0.81–1.29) | ||
| P (log-rank)* | P = 0.84 | ||
| DFS in patients with investigator-assessed CR | |||
| Patients with event, n (%) | 78 (19.8) | 93 (22.3) | |
| Stratified HR (95% CI)* | 1.19 (0.88–1.61) | ||
| Investigator-assessed EFS | |||
| Patients with event, n (%) | 265 (37.3) | 257 (36.5) | |
| Proportion of EFS at 5 years, % (95% CI) | 58.9 (54.5–63.1) | 60.6 (56.3–64.6) | |
| Stratified HR (95% CI) | 0.95 (0.80–1.12) | ||
| P (log-rank)* | P = 0.53 | ||
| Time to start of new anti-lymphoma treatment | |||
| Patients with event, n (%) | 250 (35.2) | 238 (33.8) | |
| Stratified HR (95% CI) | 0.93 (0.78–1.12) | ||
| P (log-rank)* | P = 0.45 | ||
| Investigator-assessed response rate (CT with PET) at end of treatmenta | R-CHOP (N= 665) | G-CHOP (N= 669) | |
| ORR | |||
| n (%) | 516 (77.6) | 516 (77.1) | |
| Percentage difference (95% CI) | − 0.46 (− 5.03–4.11) | ||
| CR rate | |||
| n (%) | 393 (59.1) | 378 (56.5) | |
| Percentage difference (95% CI) | − 2.60 (− 7.97–2.78) | ||
| Investigator-assessed response rate (CT without PET) at end of treatmenta | R-CHOP (N= 710) | G-CHOP (N= 704) | |
| ORR | |||
| n (%) | 569 (80.1) | 573 (81.4) | |
| Percentage difference (95% CI) | 1.25 (− 2.93–5.43) | ||
| CR rate | |||
| n (%) | 241 (33.9) | 249 (35.4) | |
| Percentage difference (95% CI) | 1.43 (− 3.61–6.46) | ||
CR complete response, DFS disease-free survival, EFS event-free survival, G-CHOP obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone, HR hazard ratio, ORR overall response rate, OS overall survival, PET positron emission tomography, PFS progression-free survival, R-CHOP rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone
*Stratification factors were International Prognostic Index and planned number of CHOP cycles (6 or 8)
aAccording to the revised response criteria