Consolidation with intraperitoneal cisplatin in first-line therapy of advanced ovarian cancer.

1991 ◽  
Vol 9 (5) ◽  
pp. 809-817 ◽  
Author(s):  
U Beller ◽  
J Speyer ◽  
N Colombo ◽  
J Sorich ◽  
J Wernz ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Median Survival ◽  
Residual Disease ◽  
Performance Status ◽  
Advanced Ovarian Cancer ◽  
Induction Phase ◽  
First Line ◽  
Control Series ◽  
Combined Modality ◽  
Initial Surgery

Seventy-five patients with advanced epithelial ovarian cancer were treated with a combined modality regimen of systemic, induction chemotherapy followed by intraperitoneal therapy (IPT). All patients underwent initial surgery for staging and/or cytoreduction followed by cisplatin 20 mg/m2 intravenously (IV) for 5 days and cyclophosphamide 600 mg/m2 on day 4 every 3 to 4 weeks for two to four cycles. Patients were then evaluated for IPT and, if eligible, had an intraperitoneal (IP) catheter placed. IPT consisted of cisplatin 60 mg/m2 in 2 L on day 1 and IV cyclophosphamide 600 mg/m2 on day 2 every 3 weeks for three to six cycles. Patients who demonstrated a clinical complete response (CCR) were then referred for second-look laparotomy (SLL). Of 71 patients who completed the induction phase, 53 (75%) were eligible for IPT, and 49 patients entered the therapy phase. Toxicity of the combined modality approach was acceptable and did not differ from our previous experience using the same drugs systemically. Thirty-two of the 49 patients who completed IPT achieved a CCR, which was confirmed by SLL in 20 patients. Twenty recurrences were documented in the 32 CCR patients, 13 occurred in patients after SLL. Projected median survival of all patients is 38 months. Median survival correlated with amount of residual disease following initial surgery (23 months for bulky v 45 months for minimal residual; P less than .001) and with performance status ([PS]; 24 months for PS 2, 3 v greater than 46 months for PS O; P less than .001). Patients who presented with bulky tumors were less likely to reach the consolidation IPT phase. Incorporation of IP cisplatin into the first-line regimen for treatment of ovarian cancer does not appear to have major impact on the survival of all treated patients when compared with our historical control series. Combined IV and IPT cisplatin and cyclophosphamide is feasible with acceptable toxicity. Its impact on response and survival may be limited to only "good-prognosis" patients.

A randomized trial comparing cisplatin plus cyclophosphamide versus cisplatin, doxorubicin, and cyclophosphamide in advanced ovarian cancer.

1986 ◽  
Vol 4 (6) ◽  
pp. 965-971 ◽  
Author(s):  
P F Conte ◽  
M Bruzzone ◽  
S Chiara ◽  
M R Sertoli ◽  
M G Daga ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Median Survival ◽  
Stable Disease ◽  
Residual Disease ◽  
Performance Status ◽  
Advanced Ovarian Cancer ◽  
Progression Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Second Look

After primary surgery, 125 patients with epithelial ovarian cancer (International Federation of Gynaecology and Obstetrics [FIGO] 1c + IIb + IIc = 22 patients, FIGO III = 82 patients, FIGO IV = 21 patients) were randomly allocated to receive PC (cisplatin 50 mg/m2 + cyclophosphamide 600 mg/m2 on day 1 every 28 days) (corrected) or PAC (PC + doxorubicin 45 mg/m2). After six cycles, patients clinically disease-free or with resectable residual disease were submitted to second-look surgery. After restaging, patients in surgical complete response (CR) stopped treatment while those responding partially (PR) received six more courses; patients whose disease progressed were excluded from the study. Among patients with measurable disease, the following clinical response rates were observed: PC = 20% CR, 34.3% PR, 14.3% stable disease, and 31.4% progression; PAC = 40.6% CR, 15.6% PR, 12.5% stable disease, and 31.3% progression. In the 75 patients submitted to second look, the results have been the following: PC = 39.5% CR, 36.8% PR, 7.9% stable disease, and 15.8% progression; PAC = 62.2% CR, 18.9% PR, 10.8% stable disease, and 8.1% progression. The difference in surgical complete response in favor of the PAC regimen is significant (P less than .05). Median survival and progression-free survival were 800 and 400 days, respectively, for PAC arm; median survival and progression-free survival were 680 and 380 days, respectively, for PC. These differences are not significant. Probability of survival was affected by FIGO stage, amount of residual disease, histology, performance status, and response at second look, while no influence was observed according to grade of tumor differentiation and age. Our results demonstrate the usefulness of doxorubicin in terms of surgical CR.

Bevacizumab, carboplatin, and paclitaxel in the first line treatment of advanced ovarian cancer patients: the phase IV MITO-16A/MaNGO-OV2A study

2021 ◽  
pp. ijgc-2021-002434
Author(s):  
Gennaro Daniele ◽  
Francesco Raspagliesi ◽  
Giovanni Scambia ◽  
Carmela Pisano ◽  
Nicoletta Colombo ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Prognostic Factors ◽  
Residual Disease ◽  
Performance Status ◽  
Advanced Ovarian Cancer ◽  
Line Treatment ◽  
First Line ◽  
Primary Surgery ◽  
First Line Treatment

ObjectiveTo explore the clinical and biological prognostic factors for advanced ovarian cancer patients receiving first-line treatment with carboplatin, paclitaxel, and bevacizumab.MethodsA multicenter, phase IV, single arm trial was performed. Patients with advanced (FIGO (International Federation of Gynecology and Obstetrics) stage IIIB-IV) or recurrent, previously untreated, ovarian cancer received carboplatin (AUC (area under the curve) 5), paclitaxel (175 mg/m2) plus bevacizumab (15 mg/kg) on day 1 for six 3-weekly cycles followed by bevacizumab single agent (15 mg/kg) until progression or unacceptable toxicity up to a maximum of 22 total cycles. Here we report the final analysis on the role of clinical prognostic factors. The study had 80% power with a two-tailed 0.01 α error to detect a 0.60 hazard ratio with a factor expressed in at least 20% of the population. Both progression-free and overall survival were used as endpoints.ResultsFrom October 2012 to November 2014, 398 eligible patients were treated. After a median follow-up of 32.3 months (IQR 24.1–40.4), median progression-free survival was 20.8 months (95% CI 19.1 to 22.0) and median overall survival was 41.1 months (95% CI 39.1 to 43.5). Clinical factors significantly predicting progression-free and overall survival were performance status, stage, and residual disease after primary surgery. Neither baseline blood pressure/antihypertensive treatment nor the development of hypertension during bevacizumab were prognostic. There were two deaths possibly related to treatment, but no unexpected safety signal was reported.ConclusionsEfficacy and safety of bevacizumab in combination with carboplatin and paclitaxel and as maintenance were comparable to previous data. Hypertension, either at baseline or developed during treatment, was not prognostic. Performance status, stage, and residual disease after primary surgery remain the most important clinical prognostic factors.Trial registration numberEudraCT 2012-003043-29; NCT01706120.

Cisplatin-cyclophosphamide versus carboplatin-cyclophosphamide in advanced ovarian cancer: a randomized phase III study of the National Cancer Institute of Canada Clinical Trials Group.

1992 ◽  
Vol 10 (5) ◽  
pp. 718-726 ◽  
Author(s):  
K Swenerton ◽  
J Jeffrey ◽  
G Stuart ◽  
M Roy ◽  
G Krepart ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Response Rate ◽  
Residual Disease ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Ovarian Cancer ◽  
Phase Iii ◽  
Treatment Center ◽  
Clinical Response Rate ◽  
Time To Progression

PURPOSE Given the potential for improved tolerance, a trial was initiated to compare the toxicity and efficacy of a standard regimen of cisplatin-cyclophosphamide (75 mg/m2 and 600 mg/m2, respectively) with an experimental regimen of carboplatin-cyclophosphamide (300 mg/m2 and 600 mg/m2, respectively) in women with postoperative macroscopic residual ovarian cancer. PATIENTS AND METHODS Between 1985 and 1989, 447 (417 eligible) patients were randomized. Treatment arms were well balanced; most patients had stage III (82%), grade 3 (54%) tumors with bulky residual (greater than 2 cm in 59%), and good performance status (Eastern Cooperative Oncology Group [ECOG] 0 or 1, 77%). Response was assessed after six 4-week cycles. RESULTS The treatments were equally deliverable, with 76% of patients completing their allocated regimen. The reported reasons for failure to complete treatment differed; toxicity/refusal predominated on the cisplatin arm, and progressive disease predominated on the carboplatin arm (P = .0092). Cisplatin-treated patients were more likely to develop neuropathy and nephropathy, and carboplatin patients experienced myelosuppression, particularly thrombocytopenia. Efficacy was similar, with no significant differences for the cisplatin and carboplatin arms in clinical response rate (57% v 59% in those with measurable disease), pathologic response rate (52% v 54% in those suitable for relaparotomy), time to progression (median, 56 v 58 weeks), or overall survival (median, 100 weeks v 110 weeks). Time to progression and survival were predicted by residual disease size, performance status, and treatment center (with those treated at centers that accrued more patients doing better). CONCLUSION Neither regimen is optimal in that relapse remains the norm. It may be inappropriate to expect that any single regimen can be an effective therapy for all patients with advanced ovarian cancer. Both cisplatin and carboplatin are likely to have a role in future treatment strategies.

Intraperitoneal chemotherapy in the management of patients with advanced epithelial ovarian cancer: a critical review of the literature

2008 ◽  
Vol 18 (5) ◽  
pp. 943-953 ◽  
Author(s):  
A. Gadducci ◽  
P. F. Conte
Keyword(s):  
Ovarian Cancer ◽  
Decision Making ◽  
Residual Disease ◽  
Progression Free Survival ◽  
High Response Rate ◽  
Phase Iii ◽  
Small Subset ◽  
First Line ◽  
Initial Surgery ◽  
Systemic Treatments

The use of intraperitoneal (IP) chemotherapy has been advocated in different settings of patients with ovarian cancer. Cisplatin is the drug of choice because of its high response rate and minimal local toxicity. This treatment can be given to women with small residual disease after second look, with surgically assessed complete response rates of approximately 30%, and with a prolonged survival in small subset of patients. However, the use of IP chemotherapy as consolidation treatment of pathologically complete responders after first-line systemic chemotherapy has not been definitively evaluated in a phase III trial. There is much debate in the literature both for and against the use of IP chemotherapy in the first-line treatment of optimally debulked ovarian cancer patients. The recent Cochrane meta-analyses of eight randomized trials enrolling 1819 patients has shown that first-line IP chemotherapy improves progression-free survival and overall survival of patients with minimal residual disease after initial surgery. However, the potential for catheter-related complications, abdominal pain with infusion, and toxicities needs to be taken into consideration for decision making in each individual woman. Rectosigmoidal surgery can be associated with gross contamination of the operative field, and in this case, the catheter placement should not be performed during primary surgery but should be delayed to 3 weeks later. Patients should be provided with information on the survival and toxicity for both IP and systemic treatments, as well as practical information about the administration of each regimen, so that they may be involved in the decision-making process

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

1988 ◽  
Vol 6 (11) ◽  
pp. 1679-1684 ◽  
Author(s):  
M S Piver ◽  
S B Lele ◽  
D L Marchetti ◽  
T R Baker ◽  
L J Emrich ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase Ii ◽  
Intraperitoneal Chemotherapy ◽  
Residual Disease ◽  
Advanced Ovarian Cancer ◽  
Stage Iii ◽  
Second Line ◽  
First Line ◽  
Ovarian Adenocarcinoma ◽  
Specific Subset

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.

Real-world bevacizumab utilization and outcomes in first-line ovarian cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5578-5578
Author(s):  
Matthew J. Monberg ◽  
Jennifer P Hall ◽  
Rebecca Moon ◽  
Olivia Higson ◽  
Kimmie McLaurin ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Performance Status ◽  
Treatment Options ◽  
Advanced Ovarian Cancer ◽  
Stage Iv ◽  
Patient Characteristics ◽  
Cross Sectional Study ◽  
First Line ◽  
Cross Sectional ◽  
The Us

5578 Background: Bevacizumab (B) is approved in combination with carboplatin and paclitaxel, followed by B monotherapy, for the treatment of advanced ovarian cancer (OC) following surgery. We sought to describe B utilization and outcomes of B in first-line (1L) OC within the US and EU. Methods: This cross-sectional study included patients who were actively receiving treatment for OC. Data were collected at a single time point from 2496 patient forms between December 2017 and March 2018 from 340 oncologists/ gynecologists across the US, France, Germany, Italy, Spain, and the UK. Patients were platinum sensitive if progression was noted > 6 months after frontline platinum therapy and resistant if the interval was 0-6 months. This analysis included patients who received 1L chemotherapy (chemo) with no maintenance or 1L chemo with bevacizumab maintenance. Results: B was used in combination with chemo at 1L and as 1L maintenance monotherapy in 11% total study patients. Those receiving 1L + B were more likely to have Stage IV disease, have good performance status (PS) at diagnosis, and receive BRCA testing than patients receiving chemo only. Treatment response, platinum sensitivity, and activities of daily living are shown in the Table. Results did not vary by BRCA status. Conclusions: This study highlights differences in patient characteristics and outcomes between patients receiving/ who received 1L chemo only and those receiving/ who received B, however, this study was not designed to formally compare 1L treatment options. [Table: see text]

Preoperative prediction of suboptimal resection in advanced ovarian cancer based on clinical and CT parameters

2016 ◽  
Vol 58 (4) ◽  
pp. 498-504 ◽  
Author(s):  
Hye Min Son ◽  
See Hyung Kim ◽  
Bo Ra Kwon ◽  
Mi Jeong Kim ◽  
Chan Sun Kim ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Logistic Regression ◽  
Group Performance ◽  
Residual Disease ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Ovarian Cancer ◽  
Cox Proportional Hazards Model ◽  
Validation Dataset ◽  
Predictive Values

Background Cytoreduction is important as a survival predictor in advanced ovarian cancer. Purpose To determine the prediction of suboptimal resection (SOR) in advanced ovarian cancer based on clinical and computed tomography (CT) parameters. Material and Methods Between 2007 and 2015, 327 consecutive patients with FIGO stage III–IV ovarian cancer and preoperative CT were included. During 2007–2012, patients were assigned to a derivation dataset ( n = 220) and the others were assigned to a validation dataset ( n = 107). Clinical parameters were reviewed and two radiologists assessed the presence or absence of tabulated parameters on CT images. Logistic regression analyses based on area under the receiver-operating characteristic curve (AUROC) were performed to identify variables predicting SOR, and generated simple score using Cox proportional hazards model. Results There was no statistical difference in patients’ characteristics in both datasets, except for residual disease ( P = 0.001). Optimal resection improved from 45.0% (99/220) in the derivation dataset to 64.4% (69/107) in the validation dataset. Logistic regression identified that Eastern Cooperative Oncology Group-performance status (ECOG-PS 2), involvements of peritoneum, diaphragm, bowel mesentery and suprarenal lymph nodes, and pleural effusion were independent variables of SOR. Overall AUROC for score predicting SOR was 0.761 with sensitivity, specificity, and positive and negative predictive values of 70.6%, 73.2%, 68.7%, and 91.9%, respectively. In the derivation dataset, AUROC was 0.792, with sensitivity of 71.4% and specificity of 74.3%, and AUROC of 0.758 with sensitivity of 69.2% and specificity of 72.8% in the validation dataset. Conclusion CT may be a useful preoperative predictor of SOR in advanced ovarian cancer.

Prognostic Value of CA125 Kinetics and Half-Life in Advanced Ovarian Cancer

2000 ◽  
Vol 15 (2) ◽  
pp. 147-152 ◽  
Author(s):  
S. Čolaković ◽  
V. Lukiç ◽  
L. Mitroviç ◽  
S. Jeliç ◽  
S. Susnjar ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Median Survival ◽  
Half Life ◽  
Prognostic Value ◽  
Residual Disease ◽  
Advanced Ovarian Cancer ◽  
Tumor Grade ◽  
Serum Levels ◽  
Survival Times ◽  
Ca125 Level

This retrospective study was undertaken in order to assess the prognostic value of prechemotherapy serum CA125 level, CA125 kinetics, and CA125 half-life compared to the ten common clinicopathological variables in patients with advanced ovarian cancer (AOC). CA125 serum levels were determined before and during induction cisplatin polychemotherapy in 222 patients. A prechemotherapy CA125 level higher than 35 U/mL was found in 134 patients. Blood samples were further obtained before each course of chemotherapy (CT). CA125 half-life values were calculated in 112 patients with CA125 levels above 60 U/mL using van der Burg's exponential regression model. The prechemotherapy CA125 level had no prognostic value for survival. However, the median survival time of patients with CA125 levels below the upper normal limit of normality after two courses of CT was 101 months compared to a median survival of 21 months in patients without CA125 normalization (p=0.0000). Half-life calculation showed a significant correlation with survival. The median survival times of patients with T 1/2 <20 days and T 1/2 >20 days were 101+ and 18 months, respectively (p=0.0003). In a survival analysis using the Cox proportional hazard model, independent prognostic variables for survival included therapeutic response (p<0.0001), Karnofsky index (p<0.0001), residual disease (p<0.0001), tumor grade (p=0.0002), CA125 half-life (p=0.007), and CA125 kinetics (p=0.04). As a consequence, the possibility to predict treatment response by the CA125 half-life during chemotherapy and the time needed for normalization of CA125 levels can divide patients into good and poor prognostic groups early during chemotherapy.

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