Brice P, Bastion Y, Lepage E, Brousse N, Haïoun C, Moreau P, Straetmans N, Tilly H, Tabah I, Solal-Céligny P
Hopital Saint-Louis, Paris, France.
J Clin Oncol. 1997 Mar;15(3):1110-7. doi: 10.1200/JCO.1997.15.3.1110.
To evaluate prospectively in patients with follicular lymphoma and a low tumor burden three therapeutic options: delay of any treatment until clinically meaningful progression, immediate treatment with an oral alkylating agent, or treatment with a biologic response modifier, interferon alfa-2b.
Newly diagnosed follicular lymphoma patients with a low tumor burden (n = 193) were randomly assigned to one of three arms: arm 1, no initial treatment (n = 66); arm 2, prednimustine 200 mg/m2/d for 5 days per month for 18 months (n = 64); or arm 3, interferon alfa 5 MU/d for 3 months then 5 MU three times per week for 15 months (n = 63). Clinical characteristics were similar in the three arms.
Overall response rates with prednimustine and interferon alfa were 78% and 70%, respectively. The overall response to therapy, when deferred, was similar at 70%. With a median follow-up duration of 45 months after randomization, the median freedom-from-treatment (FFT) interval was 24 months in arm 1 and the interval of freedom from treatment failure (FFTF) was 40 months in arm 2 and 35 months in arm 3. The median overall survival time was not reached and the overall survival rate at 5 years was 78% in arm 1, 70% in arm 2, and 84% in arm 3. Therefore, deferred treatment does not adversely influence survival at 5 years. Patients who progressed within 1 year had a significantly shorter survival duration (median, 48 months).
Delayed treatment is feasible in patients with follicular lymphoma and a low tumor burden. For patients with early progression, more intensive therapy should be considered. For others, because delay of treatment until significant clinical progression does not seem to hamper the prognosis or subsequent response to treatment, the long-term toxicity of alkylating agents can be reduced.
前瞻性评估滤泡性淋巴瘤且肿瘤负荷低的患者的三种治疗方案：延迟任何治疗直至出现具有临床意义的进展、立即使用口服烷化剂治疗或使用生物反应调节剂α-干扰素-2b治疗。
新诊断的肿瘤负荷低的滤泡性淋巴瘤患者（n = 193）被随机分配至三个治疗组之一：第1组，不进行初始治疗（n = 66）；第2组，每月连续5天给予泼尼松氮芥200 mg/m²/d，共18个月（n = 64）；或第3组，α-干扰素5 MU/d，治疗3个月，然后每周3次，每次5 MU，共15个月（n = 63）。三组的临床特征相似。
泼尼松氮芥和α-干扰素的总体缓解率分别为78%和70%。延迟治疗时的总体治疗反应相似，为70%。随机分组后中位随访时间为45个月，第1组的中位无治疗间隔时间为24个月，第2组的无治疗失败间隔时间为40个月，第3组为35个月。中位总生存时间未达到，第1组5年总生存率为78%，第2组为70%，第3组为84%。因此，延迟治疗对5年生存率无不利影响。1年内病情进展的患者生存时间显著缩短（中位值为48个月）。
对于滤泡性淋巴瘤且肿瘤负荷低的患者，延迟治疗是可行的。对于早期进展的患者，应考虑更强化的治疗。对于其他患者，由于延迟治疗直至出现明显临床进展似乎不会影响预后或后续治疗反应，可降低烷化剂的长期毒性。
