For patients with diffuse large B-cell lymphoma (DLBCL) who are unable to receive anthracycline-containing chemoimmunotherapy because of cardiac comorbidity, a regimen of rituximab (Rituxan), gemcitabine, cyclophosphamide, vincristine, and prednisolone (R-GCVP) “is an active, reasonably well-tolerated treatment,” Paul A. Fields, MD, of Guys and St. Thomas and King’s College Hospital, London, and colleagues reported in the Journal of Clinical Oncology.
The median age of the 62 patients recruited for the phase II study was 76.5 years and 69.4% had stage III or IV disease. “All patients had advanced disease; 27 (43.5%) had left-ventricular ejection fraction of ≤ 50%, and 35 (56.5%) had borderline ejection fraction of > 50% but ≤ 55% and comorbid cardiac risk factors such as ischemic heart disease, diabetes mellitus, or hypertension,” the investigators stated.
All but one patient, who died before starting treatment as a result of lung abscess, received at least one cycle of R-GCVP, administered on day 1 with gemcitabine repeated on day 8 of a 21-day cycle. The median number of cycles received was six.
The overall response rate was 61.3%. Complete response occurred in 18 patients (29.0%), undocumented/unconfirmed in 6 patients (9.7%), partial response in 14 patients (22.6%)]), “exceeding the minimum response rate required to indicate that the treatment was effective,” the researchers declared. Of the 10 patients (16.1%) who did not achieve disease response, 4 had stable disease and 6 had progressive disease. “Two-year progression-free survival for all patients was 49.8% [95% CI = 37.3–62.3], and 2-year overall survival was 55.8% [95% CI = 43.3–68.4],” the investigators reported.
Grade ≥ 3 hematologic toxicity occurred among 34 patients. “There were 15 cardiac events, of which seven were grade 1 to 2, five were grade 3 to 4, and three were fatal, reflecting the poor cardiac status of the study population,” the authors noted. Overall, 14 patients died.
“Given the group of patients presented in this study were at high risk, as defined by poor ejection fraction or borderline ejection fraction plus presence of multiple cardiac risk factors, the results emphasize that it is still possible to offer such groups of patients treatment with curative intent,” the researchers concluded. They predicted that the issue of treatment-limiting comorbidities “will become more critical in future studies as the number of elderly patients with DLBCL increases” and said that further testing of the R-GCVP regimen is warranted. ■