Kimby Eva, Schär Sämi, Pirosa Maria Cristina, Vanazzi Anna, Mey Ulrich M, Rauch Daniel, Wahlin Björn E, Hitz Felicitas, Hernberg Micaela, Johansson Ann-Sofie, de Nully Brown Peter, Hagberg Hans, Ferreri Andrés José María, Krasniqi Fatime, Voegeli Michèle, Novak Urban, Zander Thilo, Bersvendsen Hanne, Mamot Christoph, Mingrone Walter, Stathis Anastasios, Dirnhofer Stefan, Hayoz Stefanie, Østenstad Bjørn, Zucca Emanuele
Division of Hematology, Department of Medicine at Huddinge, Karolinska Institutet, Stockholm, Sweden.
Swiss Group for Clinical Cancer Research, Bern, Switzerland.
Blood Adv. 2025 Apr 8;9(7):1712-1719. doi: 10.1182/bloodadvances.2024014840.
The Swiss Group for Clinical Cancer Research (SAKK) and the Nordic Lymphoma Group conducted the SAKK 35/10 randomized phase 2 trial to compare rituximab (R) alone vs R plus lenalidomide (L) as initial treatment for follicular lymphoma (FL). Patients with grade 1 to 3A FL, requiring systemic therapy, were randomized to either R (n = 77; 375 mg/m2 IV × 1, weeks 1-4) or rituximab-lenalidomide (RL) (n = 77; R on the same schedule and L at 15 mg daily continuously). Responders (evaluated at 10 weeks) repeated R during weeks 12 to 15 with or without L (for a total of 18 weeks). Both arms had 47% of patients with a poor risk score on the FL International Prognostic Index. The primary end point, complete response (CR)/CR unconfirmed rates at 6 months, was superior with the combination, and after a median follow-up of 9.5 years, this has translated into a longer duration of response (median, not reached vs 3.2 years; hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.21-0.86; P = .014), progression-free survival (9.3 vs 2.3 years; HR, 0.57; 95% CI: 0.37-0.89; P = .0128), and time to next treatment (median, not reached vs 2.1 years; HR, 0.43; 95% CI, 0.27-0.67; P < .001). Over 60% of RL responders remained in first CR at 10 years. Overall survival was similar in both arms (77% vs 78% at 10 years; P = .881). Toxicity was more common with RL but manageable. The SAKK 35/10 trial's long-term results confirmed a durable benefit of a short-term chemotherapy-free first-line RL regimen in symptomatic FL. This trial was registered at www.clinicaltrials.gov as #NCT0137605.
瑞士临床癌症研究组织（SAKK）和北欧淋巴瘤研究组织开展了SAKK 35/10随机2期试验，以比较单独使用利妥昔单抗（R）与利妥昔单抗联合来那度胺（L）作为滤泡性淋巴瘤（FL）初始治疗方案的疗效。1至3A级FL且需要全身治疗的患者被随机分为两组，一组接受R治疗（n = 77；375mg/m²静脉注射×1次，第1 - 4周），另一组接受利妥昔单抗 - 来那度胺（RL）治疗（n = 77；R的给药方案相同，L为每日15mg持续给药）。缓解者（在第10周评估）在第12至15周重复使用R，可联合或不联合L（共18周）。两组中47%的患者根据FL国际预后指数具有不良风险评分。主要终点为6个月时的完全缓解（CR）/未确认CR率，联合治疗组更优，中位随访9.5年后，这转化为更长的缓解持续时间（中位，未达到 vs 3.2年；风险比[HR]，0.42；95%置信区间[CI]，0.21 - 0.86；P = 0.014）、无进展生存期（9.3年 vs 2.3年；HR，0.57；95% CI：0.37 - 0.89；P = 0.0128）以及至下次治疗时间（中位，未达到 vs 2.1年；HR，0.43；95% CI，0.27 - 0.67；P < 0.001）。超过60%的RL治疗缓解者在10年时仍处于首次CR状态。两组的总生存期相似（10年时分别为77%和78%；P = 0.881）。RL治疗的毒性更常见但可控制。SAKK 35/10试验的长期结果证实了短期无化疗一线RL方案对有症状FL具有持久益处。该试验在www.clinicaltrials.gov上注册，编号为#NCT0137605。
