Petrioli Roberto, Roviello Giandomenico, Laera Letizia, Luzzi Luca, Paladini Piero, Ghiribelli Claudia, Voltolini Luca, Martellucci Ignazio, Bianco Vincenzo, Francini Edoardo
Medical Oncology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
Medical Oncology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
Clin Lung Cancer. 2015 Nov;16(6):e229-34. doi: 10.1016/j.cllc.2015.05.005. Epub 2015 May 18.
Cisplatin and etoposide (PE) is the most used chemotherapy regimen in extensive-stage disease small-cell lung cancer (ED-SCLC), and usually achieves a high initial response rate. An intriguing maintenance strategy could be the combination of the angiogenic agent bevacizumab (Bev) with a convenient and well tolerated chemotherapy agent such as oral etoposide. Results of the current single-institutional phase II study suggest that a regimen that includes conventional PE chemotherapy combined with Bev followed by oral etoposide and Bev as maintenance treatment is feasible and effective in terms of 9-month disease control rate in patients with ED-SCLC.
In the present study we evaluated the efficacy and safety of a cisplatin (P), etoposide (E), and bevacizumab (Bev) regimen followed by maintenance oral E and Bev in patients with extensive-stage disease small-cell lung cancer (ED-SCLC).
Patients were administered 3-day fractionated P 25 mg/m(2) and E 100 mg/m(2) on days 1 to 3, every 3 weeks. After 3 PE cycles, all patients whose disease did not progress continued treatment with PE combined with Bev 15 mg/kg on day 3 every 3 weeks. After completion of 3 PE/Bev cycles, patients who did not experience tumor progression continued maintenance treatment with oral E 50 mg on days 1 to 14 every 21 days combined with Bev 3 times per week until occurrence of disease progression or unacceptable toxicity.
At our institution, 22 patients were enrolled and their median age was 66 years (range, 38-79 years). After completion of induction chemotherapy (3 PE cycles with 3 PE/Bev cycles) the objective response rate was in 17 patients (77.2%) (95% confidence interval [CI], 54.6-92.1). Twenty-one patients received maintenance treatment with oral E and Bev. The 9-month disease control rate was 8 patients (36.3%). Median progression-free survival was 7.8 months (95% CI, 7.0-11.3 months) and median overall survival was 13.2 months (95% CI, 11.8-18.7 months). Grade 3 to 4 neutropenia occurred in 12 patients (54.4%) and 14 patients (63.6%) of patients during cycles 1 to 3 and cycles 4 to 6 of induction chemotherapy, respectively. Severe adverse events during maintenance treatment were rarely observed.
A PE and Bev regimen followed by oral E and Bev maintenance treatment appears feasible and effective in terms of 9-month disease control rate in patients with ED-SCLC.
顺铂和依托泊苷(PE)是广泛期小细胞肺癌(ED-SCLC)中最常用的化疗方案,通常能取得较高的初始缓解率。一种有趣的维持治疗策略可能是将血管生成抑制剂贝伐单抗(Bev)与一种方便且耐受性良好的化疗药物(如口服依托泊苷)联合使用。当前单中心II期研究结果表明,对于ED-SCLC患者,一种包括传统PE化疗联合Bev,随后口服依托泊苷和Bev作为维持治疗的方案,在9个月疾病控制率方面是可行且有效的。
在本研究中,我们评估了顺铂(P)、依托泊苷(E)和贝伐单抗(Bev)方案,随后对广泛期小细胞肺癌(ED-SCLC)患者进行口服E和Bev维持治疗的疗效和安全性。
患者每3周接受3天分次给药,第1至3天给予顺铂25mg/m²和依托泊苷100mg/m²。3个PE周期后,所有疾病未进展的患者继续接受PE联合贝伐单抗15mg/kg治疗,每3周第3天给药。3个PE/Bev周期完成后,未出现肿瘤进展的患者继续接受维持治疗,口服依托泊苷50mg,每21天第1至14天给药,联合贝伐单抗每周3次,直至疾病进展或出现不可接受的毒性。
在我们机构,22例患者入组,中位年龄为66岁(范围38 - 79岁)。诱导化疗(3个PE周期加3个PE/Bev周期)完成后,17例患者(77.2%)达到客观缓解率(95%置信区间[CI],54.6 - 92.1)。21例患者接受口服E和Bev维持治疗。9个月疾病控制率为8例患者(36.3%)。中位无进展生存期为7.8个月(95% CI,7.0 - 11.3个月),中位总生存期为13.2个月(95% CI,11.8 - 18.7个月)。诱导化疗第1至3周期和第4至6周期分别有12例患者(54.4%)和14例患者(63.6%)发生3 - 4级中性粒细胞减少。维持治疗期间很少观察到严重不良事件。
对于ED-SCLC患者,PE和Bev方案随后进行口服E和Bev维持治疗,在9个月疾病控制率方面似乎是可行且有效的。