Survival with intraperitoneal cisplatin in advanced ovarian cancer after second-look laparotomy.

We studied survival in 36 patients with Stage III/IV ovarian cancer who received intraperitoneal high-dose cisplatin (200 mg/m2) alone or in combination with cytarabine (2 g), after intravenous (i.v.) cisplatin-based chemotherapy followed by second-look laparotomy. Complete responders were scheduled for three courses of IP chemotherapy, and others for six. Eight patients (22%) did not complete treatment (6 catheter failures and 2 renal failures). Peritoneal cytology remained positive in 6 patients (17%). Median overall and progression-free survival after second-look laparotomy were 44 and 37 months, respectively, for 13 complete responders to i.v. chemotherapy; 24 months and 11 months for patients with residual tumors less than 2 cm (17 cases); 15 and 12 months with tumors greater than 2 cm (6 cases). There was a significant difference in overall (p = 0.05) and progression-free (p = 0.001) survival between complete responders to i.v. chemotherapy and patients whose tumor was less than 2 cm. We find no evidence that high-dose cisplatin-based intraperitoneal chemotherapy given after second-look laparotomy will enhance survival in advanced ovarian cancer with zero or minimal residual disease.     

Phase II trial of intraperitoneal carboplatin in ovarian carcinoma patients with macroscopic residual disease at second-look laparotomy: A multicentre study of the French Federation Nationale des Centres de Lutte Contre le Cancer

BACKGROUND: Because of its antitumour activity and its pharmacological advantagewhen administered by the intraperitoneal route, carboplatinwas studied in a phase II multicen-tric trial. The aim of thestudy was to determine the response rate and the toxicity ofcarboplatin administered intraperito-neally and to determineif pathological complete response could be attained in womenwith macroscopic residual ovarian cancer at second-look laparotomyafter intravenous cis-platin chemotherapy. PATIENTS AND METHODS: Twenty-nine patients with macroscopical residual disease afterintravenous cisplatin-based chemotherapy at second-look laparotomy,were treated at that time with 300 mg/m² of carboplatin administeredin the abdominal cavity every four weeks for six cycles. Ininstances of negative findings at physical and CT scan examination,laparotomy evaluation was performed and the catheter was removed.The dose of carboplatin was increased or decreased accordingto hematological toxicity. RESULTS: Efficacy is evaluable in 25 pts: 2 pts had pathological completeresponses and 1 pt had microscopic disease (12% response rateof evaluable patients). Toxicity is evaluable for 135 cyclesin 29 patients. No grade 4 hematological toxicity was observed,2 pts had grade 3 leukopenia and 3 pts had grade 3 thrombocytopenia;grade 3 vomiting was observed in 11% of cycles. No peritonealcomplication was observed; catheter dysfunction occurred afterthe first cycle in one patient who refused a surgical procedureto remove the catheter and to pursue treatment. CONCLUSION: Intraperitoneal carboplatin demonstrates efficacy in patientswith macroscopical residual disease at second-look laparotomyafter first-line cisplatin chemotherapy. The recommended dosefor further studies is 300 mg/m² administered every 4 weeks.A low response rate does not favour a randomised study. ovarian cancer, intraperitoneal chemotherapy, carboplatin, second look     

Surgically documented response to intraperitoneal cisplatin, cytarabine, and bleomycin after intravenous cisplatin-based chemotherapy in advanced ovarian adenocarcinoma

Thirty-one evaluable patients with stages III and IV invasive ovarian adenocarcinoma were treated on a phase II protocol of second-line intraperitoneal cisplatin, cytarabine, and bleomycin. All 31 patients received first-line intravenous (IV) cisplatin-based chemotherapy; the size of the residual cancer was documented surgically before intraperitoneal chemotherapy in all patients. Response to intraperitoneal chemotherapy was documented by a third-look laparotomy in all patients not evidencing progression of disease clinically. There were eight responses (26%): five surgical complete responses and three surgical partial responses. Responders were patients with stage III ovarian cancer, small residual disease of less than or equal to 1 cm (primarily less than or equal to 5 mm), and patients who previously had responded to cisplatin-based IV chemotherapy. Of the 15 patients with stage III ovarian cancer, residual disease less than or equal to 1 cm, and those who had responded to first-line IV cisplatin-based chemotherapy, 53% (eight) responded to second-line intraperitoneal chemotherapy. Intraperitoneal chemotherapy as used in this phase II protocol would appear to be an effective second-line treatment in advanced ovarian cancer in this specific subset of patients.     

Intraperitoneal cisplatin and etoposide in the treatment of refractory/recurrent ovarian carcinoma

To determine the efficacy of a 6-month course of combination intraperitoneal (IP) chemotherapy with cisplatin and etoposide in patients with refractory or recurrent advanced ovarian carcinoma, 67 patients were entered into this prospective, nonrandomized, single-institution trial. Cisplatin at 100 mg/m2 and etoposide at 200 mg/m2 were administered IP on day 1 every month for 6 months. Exploratory laparotomy was performed before protocol entry and was planned after the completion of 6 months of IP therapy to surgically document response. All patients had received prior intravenous (IV) chemotherapy with a cisplatin-based regimen. At protocol entry, 18 (27%) patients had surgically defined residual tumor (maximal tumor diameter) greater than 2.0 cm, 17 (25%) patients greater than 0.5 cm - less than or equal to 2.0 cm, and 32 (48%) patients less than or equal to 0.5 cm. Sixteen patients (24%) who had experienced a treatment-free interval of more than 1 year prior to study entry were considered as having recurrent disease and the remaining 51 (76%) patients were considered as having refractory disease. Toxicity was tolerable: four patients (6%) had nadir fever, three (4%) had culture-documented bacterial peritonitis, five (7%) had IP catheter-related complications, and 27 (40%) had an increase in serum creatinine greater than 1.5 mg/dL. Among the 57 patients who are fully evaluable for response, the overall surgically defined response rate, complete (CR), and partial response (PR), was 40% (23/57), and the CR rate was 21% (12/57). Among the patients with recurrent disease, eight of 13 (62%) responded, with responses seen among all categories of residual disease. Among the patients with refractory disease, 15 of 44 (34%) had surgically documented responses. However, responses were more frequent in patients with residual disease less than 0.5 cm; 11 of 20 (55%) versus four of 24 (17%) with residual greater than 0.5 cm, P = .019 (chi 2, one degree of freedom, Yates correction). The duration of the CRs ranges from 4 to 18+ months. Longer follow-up is needed to determine if there is any impact on survival.     

Is there a role for intraperitoneal chemotherapy in the management of ovarian cancer?

Phase I and II clinical trial data have demonstrated the safety, pharmacokinetic advantage, and potential for enhanced cytotoxicity associated with the intraperitoneal administration of antineoplastic agents in the management of ovarian cancer. In two randomized phase III studies comparing the intraperitoneal and intravenous administration of cisplatin (Platinol) as initial therapy for small-volume residual advanced ovarian cancer, intraperitoneal delivery of the agent produced superior progression-free and overall survival. Reluctance to employ intraperitoneal cisplatin in the standard management of ovarian cancer appears to be related to the added time, effort, and potential morbidity associated with the approach, as well as a general preference for the less toxic, less complicated carboplatin (Paraplatin)-based regimen. However, existing data support the use of this unique method of drug delivery in carefully selected patients outside of the clinical trial setting.     

Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study.

PURPOSE: In randomized trials the combination of cisplatin and paclitaxel was superior to cisplatin and cyclophosphamide in advanced-stage epithelial ovarian cancer. Although in nonrandomized trials, carboplatin and paclitaxel was a less toxic and highly active combination regimen, there remained concern regarding its efficacy in patients with small-volume, resected, stage III disease. Thus, we conducted a noninferiority trial of cisplatin and paclitaxel versus carboplatin and paclitaxel in this population. PATIENTS AND METHODS: Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were randomly assigned to receive cisplatin 75 mg/m2 plus a 24-hour infusion of paclitaxel 135 mg/m2 (arm I), or carboplatin area under the curve 7.5 intravenously plus paclitaxel 175 mg/m2 over 3 hours (arm II). RESULTS: Seven hundred ninety-two eligible patients were enrolled onto the study. Prognostic factors were similar in the two treatment groups. Gastrointestinal, renal, and metabolic toxicity, as well as grade 4 leukopenia, were significantly more frequent in arm I. Grade 2 or greater thrombocytopenia was more common in arm II. Neurologic toxicity was similar in both regimens. Median progression-free survival and overall survival were 19.4 and 48.7 months, respectively, for arm I compared with 20.7 and 57.4 months, respectively, for arm II. The relative risk (RR) of progression for the carboplatin plus paclitaxel group was 0.88 (95% confidence interval [CI], 0.75 to 1.03) and the RR of death was 0.84 (95% CI, 0.70 to 1.02). CONCLUSION: In patients with advanced ovarian cancer, a chemotherapy regimen consisting of carboplatin plus paclitaxel results in less toxicity, is easier to administer, and is not inferior, when compared with cisplatin plus paclitaxel.     

The role of induction chemotherapy in inoperable ovarian cancer

Thirty patients with bulky advanced ovarian cancer surgically not resectable, received combination chemotherapy (median of 4.1 cycles; range, 3-7) including cisplatin or carboplatin, followed by a second surgical effort. Clinical CR + PR was observed in 24/30 (80%) patients after chemotherapy. Our study deals only with these 24 patients, and the 6 patients who did not respond to chemotherapy are not part of this report. At debulking, 7/24 (29.1%) patients had a complete macroscopic resection; 9/24 (37.5%) patients had a partial resection (residual tumor less than 2 cm). These data suggest that debulking is feasible and successful after chemotherapy containing cisplatin or its derivative. Overall median survival from diagnosis was 18.9 months; the 3-year survival rate was 28%. Median progression-free survival from diagnosis was 13.5 months. The results observed in our study indicate that the use of induction chemotherapy can play an important role in increasing the chances of optimal debulking in patients presenting with unresectable ovarian cancer.     

卡铂治疗卵巢恶性肿瘤的近期疗效及毒性反应——附38例分析

1989年4月～1991年5月收治卵巢恶性肿瘤38例,分别采用手术前后给予卡铂单药腹腔给药(7例),卡铂联合静脉给药(13例)与顺铂组(18例)进行对比治疗研究。结果显示卡铂单药组腹水消退明显,癌灶缩小,肠襻无粘连,手术顺利;卡铂联合组1例肿瘤明显减小,8例癌灶减至原来肿瘤的1/3,手术操作易行;而顺铂组用药后腹水量仍较多,肿瘤缩小不明显,肠粘连重致手术困难。卡铂治疗恶性卵巢肿瘤疗效突出,用药时不需水化,消化道反应轻,肾毒性小,患者易于接受,值得推广应用。     

Salvage carboplatin therapy for advanced ovarian cancer after first-line treatment with cisplatin.

From April 1989 to August 1990, 17 patients with Stage 3 or 4 epithelial ovarian cancer (EOC) were treated with intravenous carboplatin (160-400 mg/m2) for refractory or recurrent disease after first-line treatment with cisplatin-based combination chemotherapy. Of fifteen patients evaluable for activity, two complete responses and two partial responses were seen, for a response rate of 27%. The duration of response was 4.5, 5, 8, and 9.2 months, respectively, and responders survived longer than nonresponders. Of the nine evaluable patients receiving carboplatin as the first salvage treatment, four responses were seen. Dose selection for the first cycle of carboplatin was based on previous treatment, and adjustments were made on the basis of myelosuppression. In general, treatment was well tolerated--severe myelosuppression occurred after 6 of 73 cycles. This review confirms previous reports of anti-tumor activity of carboplatin in patients with refractory or recurrent advanced EOC who respond to first-line treatment with cisplatin. Further evaluation may help define the toxicity and efficacy of salvage treatment with carboplatin compared to cisplatin in patients who recur after a prolonged disease-free interval after first-line cisplatin-based therapy.     

中晚期卵巢癌术后顺铂腹腔联合紫杉醇静脉化疗的临床观察

目的:观察顺铂腹腔联合紫杉醇静脉化疗治疗中晚期卵巢癌术后患者的临床疗效和安全性.方法:回顾性分析我院2006-01-2009-12行细胞减灭术Ⅱ～Ⅳ期卵巢癌76例患者,顺铂腹腔联合紫杉醇静脉化疗36例为治疗组,并以同期行顺铂联合紫杉醇静脉化疗患者40例作为对照.比较两组患者无进展生存期(PFS)、生存率和不良反应.结果:治疗组PFS 27个月,对照组PFS 23个月,P＜0.05.治疗组1、2和3年生存率分别为97.22％(35/36)、94.44％(34/36)和88.88％(32/36),对照组1、2和3年生存率分别为95.00％(38/40)、90.00％(36/40)和77.50％(31/40).治化疗组呕吐及肾功能损伤低于对照组,而腹痛高于对照组.结论:顺铂腹腔联合紫杉醇静脉化疗治疗中晚期卵巢癌术后患者可延长患者PFS及生存率,毒副反应轻,值得临床应用.     

含紫杉醇类和卡铂的不同方案治疗卵巢癌临床分析

目的:观察紫杉醇联合卡铂经静脉、腹腔联合治疗卵巢癌的疗效及毒副作用。方法:27例卵巢上皮癌患者分为4组:A1组,泰素、卡铂静脉推注(5例);A2组,泰素静脉推注、卡铂腹腔滴注(7例);B1组,紫杉醇、卡铂静脉推注(6例);B2组紫杉醇静脉推注、卡铂腹腔化疗(9例)。观察每次化疗后的毒副作用,完成4个疗程后观察疗效。结果:27例中25例完成4个疗程,2例出现过敏性休克而中止化疗。总有效率A1组60%(3/5);A2组71.4%(5/7);B1组50%(3/6);B2组66.7%(6/9)。毒副反应比较,泰素组与紫杉醇组间及腹腔静脉联合化疗组与静脉化疗组间差异均有显著性(P<0.05)。结论:紫杉醇类与卡铂联合化疗对卵巢癌有一定疗效,腹腔静脉联合化疗毒副作用低于单纯静脉化疗,泰素组心脏毒性低于紫杉醇组。     

Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group.

PURPOSE: To compare the progression-free and overall survival in small-volume residual ovarian cancer after treatment with intravenous (IV) cisplatin and paclitaxel or an experimental regimen of IV carboplatin followed by IV paclitaxel and intraperitoneal cisplatin. PATIENTS AND METHODS: Patients were randomized to receive either IV paclitaxel 135 mg/m(2) over 24 hours followed by IV cisplatin 75 mg/m(2) every 3 weeks for six courses or IV carboplatin (area under curve 9) every 28 days for two courses, then IV paclitaxel 135 mg/m(2) over 24 hours followed by intraperitoneal (IP) cisplatin 100 mg/m(2) every 3 weeks for six courses. RESULTS: Of the 523 patients who entered this trial, 462 were determined to be assessable, with prognostic factors well balanced between the treatments. Neutropenia, thrombocytopenia, and gastrointestinal and metabolic toxicities were greater in the experimental arm. As a result, 18% of the patients received < or = two courses of IP therapy. Progression-free survival was superior for patients randomized to the experimental treatment arm (median, 28 v 22 months; relative risk, 0.78; log-rank P =.01, one-tail). There was a borderline improvement in overall survival associated with this regimen (median, 63 v 52 months; relative risk, 0.81; P =.05, one-tail). CONCLUSION: An experimental regimen including moderately high-dose IV carboplatin followed by IP paclitaxel and IV cisplatin yielded a significant improvement in progression-free survival when compared with a standard regimen of IV cisplatin and paclitaxel. Because the improvement in overall survival was of borderline statistical significance and toxicity was greater, the experimental arm is not recommended for routine use. However, the results provide direction for further clinical investigation in small-volume ovarian cancer.     

Long-term survival of advanced refractory ovarian carcinoma patients with small-volume disease treated with intraperitoneal chemotherapy

Ninety ovarian carcinoma patients failing primary intravenous (IV) combination chemotherapy were treated with cisplatin-based combination intraperitoneal therapy. Sixty-five patients had residual disease greater than 2 cm at the start of intraperitoneal therapy. Their median survival was 8 months. Twenty-five patients had disease less than 2 cm; their median survival was greater than 49 months, and the survival curve has an apparent plateau at 69%, with no relapses having occurred after 32 months. The median survival for all 90 patients was 15 months. The median duration of follow-up for all patients was 37 months. These results confirm the critical role of tumor bulk in determining the effectiveness of intraperitoneal therapy, and suggest a role for intraperitoneal salvage treatment in patients with small-volume disease.     

复发卵巢癌腹腔温热化疗联合全身化疗临床研究

目的探讨复发卵巢癌卡铂腹腔温热化疗联合多西他赛全身化疗的疗效和毒副作用。方法将70例Ⅲ～Ⅳ期复发卵巢癌患者按随机原则选择35例作为治疗组,采用卡铂腹腔温热化疗联合多西他赛全身化疗;35例作为对照组,采用卡铂联合多西他赛全身化疗,并对两组化疗后1,3,5年生存率及毒副作用对照研究,并经统计学χ2检验。结果治疗组1,3,5年生存率分别为88.6%（31/35）、65.7%（23/35）和37.1%（13/35）,对照组分别为80.0%（28/35）、51.4%（18/35）和22.9%（8/35）,两组比较差异无显著性（P〈0.05）。毒副作用主要是骨髓抑制,白细胞下降率（Ⅲ～Ⅳ度）分别为5.7%（2/35）和31.4%（11/35,P〈0.05）。结论复发卵巢癌卡铂腹腔温热化疗联合多西他赛全身化疗的疗效优于卡铂联合多西他赛全身化疗,且毒副作用轻,有利于提高患者的生存率及生存质量。     

Feasibility of intravenous gemcitabine and an intraperitoneal platinum agent in the treatment of ovarian cancer

The goal of this study is to determine the feasibility of intravenous gemcitabine and an intraperitoneal platinum agent in the treatment of patients with ovarian cancer. We performed a retrospective chart review of patients with primary, persistent or recurrent ovarian cancer, who received intravenous gemcitabine and an intraperitoneal platinum agent. Patients received gemcitabine (750 mg/m2) intravenous on days 1 and 8 and cisplatin (100 or 60 mg/m2) intraperitoneal on day 1 every 21 - 28 days. An alternate regimen was composed of gemcitabine (750 mg/m2) intravenous and carboplatin (AUC 5) intraperitoneal on day 1 every 21 days. Dose reductions occurred at the discretion of the prescribing physician.Intravenous gemcitabine and an intraperitoneal platinum agent were administered to 12 patients with advanced primary or recurrent ovarian cancer. Myelosuppression was the most common toxicity. Grade 3 or 4 thrombocytopenia, neutropenia and anemia occurred in 7, 8 and 2 patients respectively. Dose reductions were required in 7 of 12 patients. 10 of 12 patients received 6 cycles of the regimen. Treatment was discontinued prior to 6 cycles in 2 of 12 patients secondary to progression in one case and to grade 4 neutropenia and thrombocytopenia in another.The combination of intravenous gemcitabine and an intraperitoneal platinum agent appears to be a feasible regimen in patients with ovarian cancer. The most common toxicity was myelosuppression, which resulted in dose reductions in almost half of the patients.     

Improved therapeutic index of carboplatin plus cyclophosphamide versus cisplatin plus cyclophosphamide: final report by the Southwest Oncology Group of a phase III randomized trial in stages III and IV ovarian cancer.

PURPOSE: To compare cisplatin-cyclophosphamide versus carboplatin-cyclophosphamide as primary chemotherapy for stage III (suboptimal) and stage IV ovarian cancer. PATIENTS AND METHODS: Three hundred forty-two patients were randomly assigned to treatment with six courses of intravenous (i.v.) cisplatin 100 mg/m2 plus i.v. cyclophosphamide 600 mg/m2, or i.v. carboplatin 300 mg/m2 plus i.v. cyclophosphamide 600 mg/m2. RESULTS: The estimated median survivals were 17.4 and 20.0 months for the cisplatin and carboplatin study arms, respectively. The null hypothesis of a 30% survival superiority with the cisplatin arm was rejected at the P = .02 level. Clinical response rates were 52% for the cisplatin arm and 61% for the carboplatin arm. Pathologic complete response rates were similar for both study arms. There was less thrombocytopenia on the cisplatin arm (P less than .001); however, there was less nausea and emesis (P less than or equal to .001 for courses 1 to 5), renal toxicity (P less than .001), anemia (P = .01), hearing loss (P less than .001), tinnitus (P = .01), neuromuscular toxicities (P = .001), and alopecia (P less than .001) on the carboplatin arm. CONCLUSION: Carboplatin-cyclophosphamide proved to have a significantly better therapeutic index than cisplatin-cyclophosphamide in patients with stage III (suboptimal) and stage IV ovarian cancer.     

The impact of aggressive debulking surgery and cisplatin-based chemotherapy on progression-free survival in stage III and IV ovarian carcinoma

Forty consecutive patients with stage III and IV invasive ovarian carcinoma were treated on a phase II protocol consisting of optimal debulking surgery, induction cisplatin, cisplatin, doxorubicin, and cyclophosphamide (PAC) chemotherapy, 6-month interval laparoscopy, reinduction cisplatin, PAC chemotherapy, and second-look procedure. All 40 patients have either disease progression or have completed the 12-month protocol. Eighty-seven percent of the patients (35) underwent optimal (less than or equal to 2 cm residual) debulking surgery before chemotherapy, in spite of the fact that 50% (20) were referred to Roswell Park Memorial Institute (RPMI) as inoperable after initial surgery elsewhere. There were no postoperative deaths and chemotherapy was started in less than or equal to 14 days in 97% of the patients. Of the 40 patients, 30% (12) achieved a pathologic complete remission (11) or a clinical complete remission (one patient refused second-look surgery). The estimated 3-year survival rate was 62%, but the 3-year progression-free survival rate was only 29%. The median survival time was 48 months. The estimated 3-year progression-free survival rate was 31% for residual disease less than or equal to 2 cm. For the five patients with residual disease greater than 2 cm, four died within 3 years. The median survival time of patients with less than or equal to 2 cm residual disease was 48 months, as compared with 21 months for those with greater than 2 cm residual disease. Although the estimated 3-year survival rate of 62% is noteworthy, the 3-year progression-free survival rate of only 29% is probably indicative that in spite of extensive debulking surgery and cisplatin-based chemotherapy as used in this protocol, the long range proportion of patients "cured" will remain small.     

全身化疗联合腹腔化疗治疗晚期卵巢癌的临床观察

目的 观察全身化疗联合腹腔化疗对晚期卵巢癌的疗效及毒副反应.方法 24例卵巢癌,用紫杉醇135 mg/m2,卡铂400 mg/m2静滴,每4周重复1次,共化疗2个周期,顺铂60 mg,地塞米松10 mg腹腔化疗,每2周1次,进行2～3个周期,中位疾病进展时间(MTTP)9个月(5～12个月),无复发生存期5个月,观察每次化疗毒副反应及疗效.结果 24例中CR 12例、PR 7例,RR 79.2%,毒副反应为剂量限制性骨髓抑制、消化道反应.结论 全身化疗联合腹腔化疗对晚期卵巢癌有较好疗效.     

手术加皮下埋藏腹腔化疗泵联合化疗治疗晚期上皮性卵巢癌的疗效观察

目的：对晚期上皮性卵巢癌患者行手术及术中皮下埋藏腹腔化疗泵联合化疗，并对其疗效进行评价，以期对治疗提供帮助。方法：1995年8月～1997年8月收治的卵巢癌患者中24例行手术及术中皮下埋藏化疗泵，术后采用CAP方案联合化疗。顺铂50～70mg／m^2腹腔灌注，阿霉素40～60mg／m^2、环磷酰胺600～800mg／m^2静脉注射，平均4～5周为一疗程，总疗程6～12个。结果：Ⅲ期患者总有效率为77．8％；3年生存率50．0％，5年生存率25．0％。结论：彻底的手术加腹腔泵灌注腹腔化疗及静脉化疗是治疗晚期上皮性卵巢癌的有效途径，可提高患者的生活质量及生存率。     

A systematic overview of chemotherapy effects in ovarian cancer.

A systematic review of chemotherapy trials in several tumour types was performed by The Swedish Council of Technology Assessment in Health Care (SBU). The procedures for the evaluation of the scientific literature are described separately (Acta Oncol 2001; 40: 155-65). This overview on chemotherapy for epithelial ovarian cancer is based on a total of 176 scientific reports. Five meta-analyses including 17,291 patients, 33 prospective randomised studies including 12,340 patients, 36 prospective studies including 3,593 patients and one retrospective study including 421 patients. The studies include approximately 33,642 patients. The conclusions reached can be summarized into the following points: Radically operated patients with low-risk early ovarian cancer (stage IA or IB non-clear-cell well-differentiated carcinomas or borderline tumours) have a very good prognosis and there is no indication for adjuvant therapy. Radically operated patients with high-risk early ovarian cancer (clear cell carcinomas or FIGO stage IA or IB moderately or poorly differentiated carcinomas or stage IC) have a substantial risk for micrometastatic disease. However, the role of adjuvant chemotherapy is unclear and such therapy should, thus, only be used within clinical trials. The median overall survival for patients with advanced (FIGO stages II-IV) ovarian cancer randomised to paclitaxel/platinum-containing chemotherapy in three large studies ranged between 36-39 months. Compared with historical data, this represents a six to seven times longer median survival time than after surgery only. The probability for long-term survival for patients treated with a paclitaxel/platinum combination is too early to define. In two prospective randomised trials in advanced ovarian cancer, paclitaxel in combination with cisplatin has provided a survival benefit over cyclophosphamide/cisplatin. Based on these trials, paclitaxel/cisplatin is considered to be the standard treatment. This choice of standard therapy might, however, be questioned based on the results of the hitherto largest randomised study in advanced ovarian cancer, ICON3, which is, as yet only available in abstract form. It compared paclitaxel/carboplatin with carboplatin only or a platinum combination (cyclophosphamide/doxorubicin/cisplatin). There were no statistically significant differences in progression-free or overall survival. The drug regimen in the control arms of the previous studies showing superiority of the paclitaxel-cisplatin combination may not have been the optimal non-paclitaxel platinum-containing regimen. Three randomised studies have compared carboplatin/paclitaxel with cisplatin/paclitaxel. All three are hitherto only published as abstracts with short follow-up precluding survival analyses. None of them shows any difference in response rates. All three show less toxicity and one also better quality of life with carboplatin. Thus, there are preliminary data supporting the substitution of cisplatin with carboplatin. Intraperitoneal therapy with cisplatin caused improved survival compared with intravenous therapy in one ramdomised study. Further studies have shown trends to better survival and longer progression-free interval with intraperitoneal therapy. The accrual to studies on intraperitoneal chemotherapy has been poor reflecting that it is a cumbersome and not easily accepted treatment. In advanced ovarian cancer, no convincing advantage has been shown from more dose-intensive chemotherapy, without cytokines or bone marrow stem cell support, compared with standard doses. High response rates are achieved with high-dose chemotherapy with stem cell support in the salvage situation but response duration is short. Phase III studies evaluating high-dose chemotherapy in the first-line situation are ongoing. Until supportive controlled clinical trials are presented, high-dose chemotherapy should be confined to clinical trials. Tumour response is frequently observed on re-treatment with the same drugs as given first-line in patients sensitive to first-line platinum-based chemotherapy with a long progression-free interval. Thus, in these patients treatment with a platinum/paclitaxel combination might be recommended. albeit based on limited data. In patients resistant to first-line therapy, a number of single agents induce tumour responses in the range of 10-30%. The literature does not permit general treatment recommendations in these patients, which are recommended to be included in controlled clinical trials.