Sunitinib administered on 2/1 schedule in patients with metastatic renal cell carcinoma: the RAINBOW analysis

被引：81

作者：

Bracarda, S. ^{[1
]}

Iacovelli, R. ^{[2
]}

Boni, L. ^{[3
]}

Rizzo, M. ^{[4
]}

Derosa, L. ^{[5
]}

Rossi, M. ^{[6
]}

Galli, L. ^{[7
]}

Procopio, G. ^{[2
]}

Sisani, M. ^{[1
]}

Longo, F. ^{[8
]}

Santoni, M. ^{[9
]}

Morelli, F. ^{[10
]}

Di Lorenzo, G. ^{[11
]}

Altavilla, A. ^{[12
]}

Porta, C. ^{[13
]}

Camerini, A. ^{[14
]}

Escudier, B. ^{[5
]}

机构：

[1] Osped San Donato USL8, ITT, Arezzo, Italy

[2] Ist Nazl Tumori, I-20133 Milan, Italy

[3] Ist Toscano Tumori, AOU Careggi, Clin Trials Coordinating Ctr, Florence, Italy

[4] AORN Cardarelli, Med Oncol, Naples, Italy

[5] Inst Gustave Roussy, Dept Med Oncol, Paris, France

[6] Osped Santa Maria Misericordia, Med Oncol, Perugia, Italy

[7] Polo Oncol AOU Pisana, Pisa, Italy

[8] Policlin Umberto 1, Med Oncol A, Rome, Italy

[9] Polytech Univ Marche Reg, Med Oncol, Ancona, Italy

[10] IRCCS Casa Sollievo Sofferenza, Med Oncol, San Giovanni Rotondo, Italy

[11] AOU Federico II, Genitourinary Canc Sect, Naples, Italy

[12] Policlin Umberto 1, Med Oncol B, Rome, Italy

[13] IRCCS San Matteo, Pavia, Italy

[14] Az USL12, Osped Versilia, UO Oncol Med, Lido Di Camaiore, Italy

来源：

ANNALS OF ONCOLOGY | 2015年 / 26卷 / 10期

关键词：

mRCC; sunitinib; treatment schedule; toxicity; INTERFERON-ALPHA; DOSING SCHEDULE; CANCER; TOXICITY; MANAGEMENT; OUTCOMES; THERAPY; TRIAL;

D O I：

10.1093/annonc/mdv315

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: First-line sunitinib is recommended in metastatic renal cell carcinoma (mRCC), but it is frequently associated with relevant toxicities and subsequent dose reductions. Alternative schedules, such as 2-week-on treatment and 1-week-off (2/1 schedule), might improve tolerability. We evaluated the safety and outcomes of this schedule in a large multicenter analysis. Patients and methods: Retrospective, multicenter analysis of mRCC patients treated with first-line sunitinib on a 2/1 schedule. Data of 249 patients were reviewed: 208 cases who started sunitinib on the 4/2 schedule (full dosage: 188/208, 90.4%) and thereafter switched to the 2/1 schedule for toxicity (group 4/2. 2/1) and 41 patients who started first-line sunitinib with the 2/1 schedule because of suboptimal clinical conditions (group 2/1). A total of 211 consecutive patients treated with the 4/2 schedule in another institution served as external controls. Safety was the primary end point. Treatment duration (TD), progression-free survival (PFS) and overall survival (OS) were also analyzed. Results: In group 4/2 -> 2/1, the overall incidence of grade >= 3 toxicities was significantly reduced (from 45.7% to 8.2%, P < 0.001) after the switch to 2/1 schedule. This advantage was maintained also in the 106/188 cases (56.4%) who maintained the full dosage. Fatigue, hypertension, hand-foot syndrome and thrombocytopenia were less frequent. The incidence of grade >= 3 adverse events in the negatively selected group 2/1 (only 73.2% starting at full dose) was 26.8%, similar to what observed in the external control group (29.4%). Median TD was 28.2 months in the 4/2 -> 2/1 group (total time spent with both schedules), 7.8 months in the 2/1 group and 9.7 months in external controls. Median PFS was 30.2, 10.4 and 9.7 months, respectively. Median OS was not reached, 23.2 and 27.8 months, respectively. Conclusions: mRCC patients who moved to a modified 2/1 schedule of sunitinib experience an improved safety profile compared with that observed during the initial 4/2 schedule.

引用

页码：2107 / 2113

页数：7

共 23 条

[1] Clinical Outcomes for Patients with Metastatic Renal Cell Carcinoma Treated with Alternative Sunitinib Schedules [J].