Gadducci A, Carnino F, Chiara S, Brunetti I, Tanganelli L, Romanini A, Bruzzone M, Conte P F
Department of Reproductive Medicine, University of Pisa, Italy.
Gynecol Oncol. 2000 Feb;76(2):157-62. doi: 10.1006/gyno.1999.5677.
Intraperitoneal chemotherapy has a strong biological and pharmacological rationale in the treatment of ovarian cancer. From 1989 to 1996 the present study included 113 patients with FIGO stage II-IV ovarian cancer with residual disease less than 2 cm who were randomly allocated to receive 50 mg/m(2) intraperitoneal cisplatin (CDDP) plus 60 mg/m(2) intravenous epidoxorubicin (EPIDOX) and 600 mg/m(2) intravenous cyclophosphamide (CTX) (ipPEC arm) or 50 mg/m(2) intravenous CDDP plus 60 mg/m(2) intravenous EPIDOX and 600 mg/m(2) intravenous CTX (ivPEC arm). Chemotherapy was repeated every 4 weeks for six cycles. Treatment protocol was changed in 22 patients, 2 from the iv arm (who received single-agent carboplatin) and 20 from the ip arm (who were crossed to systemic chemotherapy, ivPEC, or single-agent carboplatin). At the end of chemotherapy, a second-look was performed in 33 of the 54 patients from the ip arm and in 34 of the 57 patients from the systemic arm. The pathologic complete response rate was 41% of all entered patients and 69% of patients submitted to second-look. No significant difference in pathologic response rate as well as in hematologic and nonhematologic toxicities was seen between the two arms. Up to September 1998, 72 patients showed a disease recurrence (33 treated with ipPEC and 39 treated with ivPEC), 55 died (22 ipPEC and 30 ivPEC), and 10 were lost to follow-up (6 ipPEC and 4 ivPEC). Median progression-free survival was 42 and 25 months for ipPEC and ivPEC, respectively (p = 0.13). Median overall survival was 67 and 51 months for ipPEC and ivPEC, respectively (p = 0.14). In conclusion, besides confirming that intraperitoneal chemotherapy is feasible with acceptable toxicity but with poor compliance in community hospitals, this trial showed that intraperitoneal CDDP compared with intravenous CDDP in combination with EPIDOX and CTX obtained a slight (not significant) improvement in progression-free survival and overall survival of optimally cytoreduced advanced ovarian cancer patients.
腹腔内化疗在卵巢癌治疗中具有强大的生物学和药理学依据。1989年至1996年，本研究纳入了113例国际妇产科联盟（FIGO）II-IV期卵巢癌且残留病灶小于2 cm的患者，这些患者被随机分配接受50 mg/m²腹腔内顺铂（CDDP）加60 mg/m²静脉表柔比星（EPIDOX）和600 mg/m²静脉环磷酰胺（CTX）（腹腔内化疗联合顺铂、表柔比星和环磷酰胺组）或50 mg/m²静脉CDDP加60 mg/m²静脉EPIDOX和600 mg/m²静脉CTX（静脉化疗联合顺铂、表柔比星和环磷酰胺组）。化疗每4周重复一次，共六个周期。22例患者的治疗方案发生了改变，2例来自静脉化疗组（接受单药卡铂治疗），20例来自腹腔内化疗组（改为全身化疗、静脉化疗联合顺铂、表柔比星和环磷酰胺或单药卡铂治疗）。化疗结束时，腹腔内化疗组的54例患者中有33例进行了二次探查，静脉化疗组的57例患者中有34例进行了二次探查。病理完全缓解率在所有入组患者中为41%，在接受二次探查的患者中为69%。两组在病理缓解率以及血液学和非血液学毒性方面均未观察到显著差异。截至1998年9月，72例患者出现疾病复发（33例接受腹腔内化疗联合顺铂、表柔比星和环磷酰胺治疗，39例接受静脉化疗联合顺铂、表柔比星和环磷酰胺治疗），55例死亡（22例腹腔内化疗联合顺铂、表柔比星和环磷酰胺治疗，30例静脉化疗联合顺铂、表柔比星和环磷酰胺治疗），10例失访（6例腹腔内化疗联合顺铂、表柔比星和环磷酰胺治疗，4例静脉化疗联合顺铂、表柔比星和环磷酰胺治疗）。腹腔内化疗联合顺铂、表柔比星和环磷酰胺组和静脉化疗联合顺铂、表柔比星和环磷酰胺组的无进展生存期中位数分别为42个月和25个月（p = 0.13）。腹腔内化疗联合顺铂、表柔比星和环磷酰胺组和静脉化疗联合顺铂、表柔比星和环磷酰胺组的总生存期中位数分别为67个月和51个月（p = 0.14）。总之，除了证实腹腔内化疗可行且毒性可接受，但在社区医院依从性较差外，本试验还表明，与静脉CDDP联合EPIDOX和CTX相比，腹腔内CDDP在最佳细胞减灭的晚期卵巢癌患者的无进展生存期和总生存期方面有轻微（不显著）改善。
Zotero 插件