Table 3. Primary outcome (complete remission rate after 3 cycles) and secondary outcomes of effectiveness, including best-documented response achieved during whole treatment course, progression-free survival and overall survival.
| Response after three cycles | R-MPL (N=69) | R-MP (N=38) | All (N=107) |
|---|---|---|---|
| CR | 26 (37.7, 26.5–50.2) | 12 (31.6, 18.0–48.8) | 38 (35.5, 26.5–45.4) |
| PR | 6 (8.7, 3.6–18.6) | 9 (23.7, 12.0–40.6) | 15 (14.0, 8.3–22.4) |
| SD | 0 | 0 | 0 |
| PD/relapse | 8 (11.6, 5.5–22.1) | 4 (10.5, 3.4–25.7) | 12 (11.2, 6.2–19.1) |
| Not done | 29 (42.0, 30.4–54.5) | 13 (34.2, 20.1–51.4) | 42 (42.1, 32.7–52.0) |
| Best response achieved | |||
| CR | 30 (43.5, 31.8–55.9) | 15 (39.5, 24.5–56.5) | 45 (42.1, 32.7–52.0) |
| PR | 20 (29.0, 19.0–41.3) | 14 (36.8, 22.3–54.0) | 34 (31.8, 23.3–41.6) |
| SD | 1 (1.4, 0.08–8.9) | 0 | 1 (0.9, 0.05–5.8) |
| PD | 1 (1.4, 0.08–8.9) | 1 (2.6, 0.1–15.4) | 2 (1.9, 0.3–7.3) |
| Not done | 17 (24.6, 15.4–36.7) | 8 (21.1, 10.1–37.8) | 25 (23.4, 16.0–32.7) |
| Progression-free survival | |||
| Median months (95% CI) | 9.6 (4.8–24.0) | 11.2 (5.7–27.3) | 10.3 (6.5–15.9) |
| 1-year rate % (95% CI) | 44.9 (33.2–56.7) | 48.9 (32.8–65.0) | 46.3 (36.8–55.8) |
| 2-year rate % (95% CI) | 38.8 (27.2–50.4) | 34.9 (19.3–50.4) | 37.3 (28.0–46.6) |
| Overall survival | |||
| Median months (95% CI) | 15.4 (7.7–44.8) | 22.6 (10.3 – inf) | 20.7 (10.7–44.8) |
| 1-year rate % (95% CI) | 53.6 (41.9–65.4) | 62.4 (46.8–78.0) | 56.7 (47.2–66.1) |
| 2-year rate % (95% CI) | 46.0 (34.1–57.8) | 47.9 (30.4–65.3) | 47.0 (37.3–56.7) |
Abbreviations: CI, confidence interval; CR, complete remission; PD, progressive disease; PR, partial remission; R-MP, rituximab, methotrexate and procarbazine; R-MPL, rituximab, methotrexate, procarbazine and lomustine; SD, stable disease.
Numbers are frequencies (proportion, 95% CI) if not stated otherwise.