Interferon alfa-2b combined with cytarabine versus interferon alone in chronic myelogenous leukemia (French Chronic Myeloid Leukemia Study Group)
Phase 3
- Population
- Previously untreated people with chronic myelogenous leukemia in chronic phase.
- Design
- Randomized trial in previously untreated chronic-phase CML; stopped when a sequential analysis showed a benefit of interferon plus cytarabine. Endpoints stated: overall survival, complete hematologic remission at 6 months, major cytogenetic response at 12 months.
- Arms
- Interferon alfa-2b with hydroxyurea (control, n = 361): Hydroxyurea (50 mg per kg per day) and interferon alfa-2b (5 million units per square metre per day)
- Interferon alfa-2b with hydroxyurea plus cytarabine (experimental, n = 360): Same hydroxyurea and interferon doses plus monthly courses of cytarabine (20 mg per square metre per day for 10 days)
- People
- Guilhot F, senior author Tanzer J, French Chronic Myeloid Leukemia Study Group
Δ 36-month OS+6.6 pointsΔ MCyR+17 points
Show the numbers
| Endpoint | Analysis | Interferon alfa-2b with hydroxyurea plus cytarabine | Interferon alfa-2b with hydroxyurea | Effect |
|---|---|---|---|---|
| OSRandomized patients (360 interferon-cytarabine, 361 interferon, as named in the abstract) | primaryGuilhot 1997 | 85.7% at 3 y | 79.1% at 3 y | P=0.02The abstract names the comparison as 360 patients (interferon-cytarabine) versus 361 (interferon). It reports a 'relative risk of death' of 0.64 (95 percent CI 0.44 to 0.93) and does not call it a hazard ratio, so it is not entered in the hazard-ratio field. |
| MCyRPatients assessed at 12 months (311 interferon-cytarabine, 314 interferon)Less than 35 percent Philadelphia chromosome-positive cells in the bone marrow. | primaryGuilhot 1997 | 41% | 24% | P<0.001126 of 311 patients with interferon-cytarabine and 75 of 314 with interferon alone. |
| Endpoint | Analysis | Interferon alfa-2b with hydroxyurea plus cytarabine | Interferon alfa-2b with hydroxyurea | Effect |
|---|---|---|---|---|
| OSRandomized patients (360 interferon-cytarabine, 361 interferon, as named in the abstract) | primaryGuilhot 1997 | 85.7% at 3 y | 79.1% at 3 y | P=0.02The abstract names the comparison as 360 patients (interferon-cytarabine) versus 361 (interferon). It reports a 'relative risk of death' of 0.64 (95 percent CI 0.44 to 0.93) and does not call it a hazard ratio, so it is not entered in the hazard-ratio field. |
| MCyRPatients assessed at 12 months (311 interferon-cytarabine, 314 interferon)Less than 35 percent Philadelphia chromosome-positive cells in the bone marrow. | primaryGuilhot 1997 | 41% | 24% | P<0.001126 of 311 patients with interferon-cytarabine and 75 of 314 with interferon alone. |