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一种改良的门诊静脉/腹腔化疗方案用于Ⅲ期卵巢癌理想减瘤术后的可行性及安全性

Feasibility and safety of a modified outpatient regimen with intravenous/intraperitoneal chemotherapy for optimally debulked stage III ovarian cancer.

作者信息

Bruixola Gema, Domingo Santiago, Díaz Roberto, Caballero Javier, Palomar Laura, De La Cueva Helena, Santaballa Ana

机构信息

Departments of *Medical Oncology and †Obstetrics and Gynaecology, La Fe University and Polytechnic Hospital, Valencia, Spain.

出版信息

Int J Gynecol Cancer. 2015 Feb;25(2):214-21. doi: 10.1097/IGC.0000000000000330.

Abstract

OBJECTIVE

Intraperitoneal (i.p.) chemotherapy improves survival in optimally debulked ovarian cancer patients. However, the need for inpatient administration and the perceived higher toxicity rates compared with standard intravenous chemotherapy have limited its widespread application. Several modified outpatient schemes, such as the Spanish Ovarian Cancer Research Group (GEICO) regimen, have been tested and have reported overall better tolerance with an improvement in completion treatment rates. The aim of our study was to assess the toxicity of the GEICO regimen in patients treated at our institution.

METHODS

We reviewed clinical records of stage III ovarian cancer patients with optimally debulked primary cytoreduction surgery that were treated from June 2009 to April 2013 with the GEICO regimen. Patients received intravenous paclitaxel (175 mg/m2) for 3 hours on day 1, i.p. cisplatin (100 mg/m2) on day 2, and i.p. paclitaxel (60 mg/m2) on day 8 every 21 days for a maximum of 6 cycles.

RESULTS

Twenty-one patients were identified. In 67% of the patients, i.p. port placement was performed at the primary surgery. The most common grade 3-to-4 toxicities seen were abdominal pain (14.3%) and neurotoxicity (9.5%). Eighteen patients (85.7%) completed the 6 cycles. Three patients stopped chemotherapy because of treatment-related toxicity. There were no serious port-related complications. With a median follow-up of 46 months, median progression-free survival was 23 months (95% confidence interval [11.8-34.6]). Nine patients (42.9%) have relapsed; most relapses were multifocal and extraperitoneal.

CONCLUSION

The administration of the GEICO outpatient modified regimen was feasible with a good safety profile. It seems to show less toxicity than previously reported IP chemotherapy regimens. In our institution, port-related complications were infrequent and easily managed. However, further studies are warranted to establish the optimal i.p. regimen in a prospective manner and to validate it in a larger phase 3 trial.

摘要

目的

腹腔内(i.p.)化疗可提高经最佳肿瘤细胞减灭术治疗的卵巢癌患者的生存率。然而,与标准静脉化疗相比,腹腔内化疗需要住院给药且被认为毒性率更高,这限制了其广泛应用。一些改良的门诊方案,如西班牙卵巢癌研究组(GEICO)方案,已经进行了测试,并报告总体耐受性更好,完成治疗率有所提高。我们研究的目的是评估GEICO方案在我院接受治疗的患者中的毒性。

方法

我们回顾了2009年6月至2013年4月期间接受GEICO方案治疗的III期卵巢癌患者的临床记录,这些患者均接受了最佳肿瘤细胞减灭术。患者在第1天静脉输注紫杉醇(175mg/m²)3小时,第2天腹腔注射顺铂(100mg/m²),第8天腹腔注射紫杉醇(60mg/m²),每21天重复一次,最多进行6个周期。

结果

共纳入21例患者。67%的患者在初次手术时进行了腹腔置管。最常见的3-4级毒性反应为腹痛(14.3%)和神经毒性(9.5%)。18例患者(85.7%)完成了6个周期的治疗。3例患者因治疗相关毒性反应而停止化疗。未发生严重的与置管相关的并发症。中位随访46个月,中位无进展生存期为23个月(95%置信区间[11.8-34.6])。9例患者(42.9%)复发;大多数复发为多灶性且位于腹膜外。

结论

GEICO门诊改良方案的给药是可行的,安全性良好。与先前报道的腹腔内化疗方案相比,其毒性似乎更小。在我院,与置管相关的并发症很少见且易于处理。然而,有必要进行进一步研究,以前瞻性方式确定最佳腹腔内化疗方案,并在更大规模的3期试验中进行验证。

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