Peterson 2003.
| Methods | RCT Location: USA, multicenter, CALGB study Years: 1980 to1985 Follow‐up: maximum 18 years Pharmaceutical sponsorship: NR Classification system: REAL Central pathology: yes |
|
| Participants | Number of patients randomized: 228 Number of patients analyzed: 228 Numbers of patients with FL: 189 after reclassification Lymphoma: advanced FL grade 1 (follicular small cell lymphoma) and grade 2 (follicular mixed‐cell lymphoma) Line of treatment: first Patients: median age 55 years, 36% of patients were over 60 years, 60% had bone marrow involvement, 50% were asymptomatic at initiation of treatment |
|
| Interventions | Different: CHOP‐Bleo for a median of 26 months (Bleo only 6 cycles) versus daily cyclophosphamide PO for a median of 28 months | |
| Outcomes | Overall survival Response rate TTTP ‐ time to first progression, relapse or recurrence, death from any cause, or discontinuation of treatment for non‐responders CR duration ‐ from first CR to relapse or death by any cause Toxicity |
|
| Notes | Published: journal article Subgroup analysis of FSCL and FML patients, after reclassification, indicated better outcomes in FML patients treated with CHOP regimen, including overall survival, TTTF and complete remission duration |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported. No statement regarding where randomization actually took place |
| Allocation concealment (selection bias) | Unclear risk | Not reported. No statement regarding where randomization actually took place |
| Blinding (performance bias and detection bias) All outcomes | High risk | Open study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 6 of 234 randomized patients were cancelled, 3 in each arm (reasons not stated). Data were reported for 228 patients. Another analysis was made to compare between grades of FL (FSCL versus FML), and included 189 patients with after central pathology review |
| Selective reporting (reporting bias) | Unclear risk | Protocol unavailable |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Open study; review authors do not believe this will introduce bias |