scholarly journals Comparison of clinico-pathological characteristics and survival of recurrent ovarian cancer patients on seven different chemo-protocols

2019 ◽  
Vol 69 (1) ◽  
pp. 87-97
Author(s):  
Saima Sattar ◽  
Mobasher Ahmad ◽  
Hamid Saeed ◽  
Zikria Saleem ◽  
Zeeshan Danish ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Histological Grade ◽  
Progression Free Survival ◽  
Complete Response ◽  
Recurrent Ovarian Cancer ◽  
Figo Stage ◽  
Care Hospital ◽  
Pathological Characteristics ◽  
Literature Evidence

Abstract Despite growing prevalence of ovarian cancer (OC) in Pakistan, no literature evidence exists regarding its clinic-pathological characteristics, survival and compliance of patients with recurrent ovarian cancer on various chemo-protocols. An observational study was conducted by enrolling 251 recurrent OC patients on 7 different chemo-protocols, from a specialized cancer care hospital, Lahore, Pakistan, using convenient judgmental sampling. The study was conducted for a period of 6 months. Most of the patients were between 18 and 70 years of age, with IIIC FIGO stage and papillary serous histological grade. As per RECIST, improved partial response (PR) (63.3 %) and complete response (CR) (52.1 %) was observed in the CP (carboplatin + paclitaxel) arm, substantiated by improved median progression free survival (PFS) and overall survival (OS) in CP and CD (carboplatin + docetaxel) arms, respectively, yet with no significant differences in survival curves, PFS (p = 0.12) and OS (p = 0.22). Interestingly, the highest and the lowest patient non-compliance were observed in CG (carboplatin + gemcitabine) (81.6 %) and paclitaxel (4.5 %) arms, resp. As per the hazard model for survival, topotecan showed significant association with the therapy related events/deaths compared to other protocols. These data suggest that CP regimen exhibited improved clinical efficacy and decreased toxicity related non-compliance in recurrent ovarian cancer patients of Lahore.

Apatinib as a salvage treatment in gynecologic cancer patients failed from two or more lines of prior chemotherapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17009-e17009 ◽  
Author(s):  
Congying Xie ◽  
Meng Su ◽  
Xiance Jin
Keyword(s):  
Ovarian Cancer ◽  
Cervical Cancer ◽  
Cancer Patients ◽  
Gynecologic Cancer ◽  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Recurrent Ovarian Cancer ◽  
Kaplan Meier ◽  
Hand Foot Syndrome

e17009 Background: The aim of this study was to evaluate the efficacy and safety of apatinib, an oral VEGFR2 inhibitor, in the treatment of advanced cervical and ovarian cancer patients who failed from two or more lines of chemotherapy. Methods: The advanced cervical and ovarian cancer patients, who experienced two or more lines of chemotherapy and treated with apatinib from April 2015 to January 2017, were retrospectively reviewed. All eligible patients received continuous apatinib treatment until disease progression, death, or intolerable toxicity. Survival and toxicities outcome were evaluated by Kaplan-Meier method and according to NCI-CTC4.0. Results: Twenty-six patients were eligible (cervical cancer:12 and ovarian cancer:14). After dose adjustment, 14 patients (53.8%) received 500 mg daily of apatinib, 8 patients received 250mg, 3 received 425mg and 1 received 675mg daily. The median progression-free survival (PFS) of cervical cancer and ovarian cancer were 8 months (95%CI:3.83-12.17) and 4 months (95%CI:1.57-6.44), respectively. Objective response rates in cervical cancer and ovarian cancer were 50% and 50%, respectively. Disease control rates were 100% for cervical cancer and 71.4% for ovarian cancer. Complete response was not observed in either cervical cancer or ovarian cancer. A 52-year old patient with recurrent ovarian cancer, experienced two lines of chemotherapy failure, was orally administered with apatinib at a dose of 250mg daily from November 2015, got partial response (PR) after one month, PFS have not yet reach. A 43-year old female patient with advanced cervical cancer, experienced three lines of chemotherapy failure, was orally administered with apatinib at a dose of 250mg daily from September 2015, got PR with a PFS of 14 months. The toxicities associated with apatinib treatment was generally acceptable with 8 patients developed grade 3/4 toxicity. The most common adverse events in this study were hypertension(n = 17), hand-foot syndrome(n = 24), and mouth mucositis(n = 20). Conclusions: Apatinib monotherapy showed promising efficiency with tolerable toxicity for advanced/recurrent cervical and ovarian cancer patients who failed from two or more lines of chemotherapy.

Pegylated liposomal doxorubicin re-challenge in patients with ovarian cancer relapse: a multicenter retrospective study

2019 ◽  
Vol 29 (1) ◽  
pp. 153-157 ◽  
Author(s):  
Elisa Tripodi ◽  
Gennaro Cormio ◽  
Ugo De Giorgi ◽  
Giorgio Valabrega ◽  
Daniela Rubino ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Liposomal Doxorubicin ◽  
Objective Response ◽  
Pegylated Liposomal Doxorubicin ◽  
Complete Response ◽  
Recurrent Ovarian Cancer ◽  
Hematological Toxicity ◽  
Cancer Relapse ◽  
Platinum Agent

BackgroundPegylated liposomal doxorubicin (PLD) is an active and well-tolerable treatment in ovarian cancer relapse, either alone or in combination with other drugs. No data are available on the possibility to rechallenge PLD treatment in long survivor patients with recurrent ovarian cancer, as evaluated for platinum agent, paclitaxel and gemcitabine. The aim of the present study was to evaluate the anti-tumor activity and the toxicity profile of re-challenge of PLD in recurrent ovarian cancer patients.MethodsData on 27 patients with epithelial ovarian cancer treated in the last ten years (2007-2017) with palliative PLD rechallenge were included in this multicenter retrospective Italian study.ResultsThe objective response rate to PLD re-treatment were complete response in 19%, partial response in 30% and stable disease in 37%. Only 1 case of G4 hematological toxicity was reported. No patient experienced severe cardiac impairment (G2-4).ConclusionPLD rechallenge represents an active and safe possibility of treatment for long survivor ovarian cancer patients.

Survival and prognostic factors in patients with epithelial ovarian cancer receiving paclitaxel and carboplatin as first-line chemotherapy in Japanese women: A multi-center retrospective study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15022-15022
Author(s):  
H. Kajiyama ◽  
F. Kikkawa ◽  
M. Kawai ◽  
K. Mizuno ◽  
I. Kobayashi ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Prognostic Factors ◽  
Retrospective Study ◽  
Epithelial Ovarian Cancer ◽  
Clear Cell ◽  
Histological Grade ◽  
Clinical Stage ◽  
Progression Free Survival ◽  
Figo Stage ◽  
Second Line

15022 Background: The aim of this retrospective study was to re-evaluate, multi-analytically, survival and prognostic factors of patients with epithelial ovarian cancer (EOC) receiving the combination of paclitaxel and carboplatin (PC). Methods: Between 1/00 and 12/04, a total of 335 cases with EOC of FIGO stage I-IV are registered in a multi-institutional series. All patients received cytoreductive surgery and combination chemotherapy of paclitaxel 180 mg/m2/3 hr and carboplatiion AUC = 5 for a total of 6 cycles. We retrospectively analyzed progression-free survival (PFS) and overall survival (OS) of these patients by stratification of assumable several prognostic factors and second-line regimen. Survival probabilities were estimated by Kaplan-Meier methods, and prognostic factors for survival were evaluated by a COX proportional hazard model. Results: Median age was 54 ± 11 years (range 9–81). The 3-, 4- and 5-year OS in patients was 67.0%, 53.9% and 50.6%, respectively. In a COX analysis, FIGO stage, histological type and residual tumor (2 cm < vs. 2 cm >; P = 0.0007, HR; 2.4, 95% CI = 1.4–4.0) were found to be independent significant factors for OS. The stratification analysis revealed that stage III-IV patients with clear cell and mucinous carcinoma have poorer prognosis than those with other histological types ( Table ). In contrast, no differences in histological grade (G1 vs. G2; P = 0.82, HR; 0.9, 95% CI = 0.5–1.6, G1 vs. G3; P = 0.65, HR; 0.9, 95% CI = 0.4–1.6) and kinds of second-line regimen were noticed for PFS and OS. Conclusions: Optimal surgical debulking, clinical stage, and histology appear to be important prognostic factors of survival in patients with EOC. This retrospective study suggests that PC may still have an impact on outcome. However, further strategy will be needed for improving survival of mucinous and clear-cell type EOC, especially with advanced stage. [Table: see text] No significant financial relationships to disclose.

scholarly journals The impact of STAT3 and phospho-STAT3 expression on the prognosis and clinicopathology of ovarian cancer: a systematic review and meta-analysis

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Shuo Gao ◽  
Wenyuan Zhang ◽  
Na Yan ◽  
Min Li ◽  
Xiaowei Mu ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ovarian Cancer ◽  
Cancer Patients ◽  
Ovarian Tissue ◽  
Meta Analysis ◽  
Prognostic Significance ◽  
Progression Free Survival ◽  
Figo Stage ◽  
Clinicopathologic Characteristics ◽  
The Impact

Abstract Purpose STAT3 and p-STAT3 are often overexpressed in various human tumours and participate in cancer development and progression. However, whether STAT3/p-STAT3 expression is associated with clinicopathologic characteristics and has prognostic significance for people suffering from ovarian cancer remains controversial. We conducted a systematic review and meta-analyses to clarify the associations between STAT3/p-STAT3 expression and clinicopathologic characteristics and prognostic factors of ovarian cancer. Methods A systematic electronic search in the PubMed, Embase, CNKI, and Wanfang databases was conducted to identify relevant articles published before 3 April 2021. All statistical analyses were performed using Stata 15.1. Results We included 16 eligible studies incorporating 1747 ovarian cancer patients. The expression of STAT3/p-STAT3 was upregulated in ovarian cancer samples versus normal ovarian tissue, benign tumours and borderline tumours (OR = 10.14, p < 0.00001; OR = 9.08, P < 0.00001; OR = 4.01, p < 0.00001, respectively). STAT3/p-STAT3 overexpression was significantly correlated with FIGO stage (I-II vs. III-IV) (OR = 0.36, p < 0.00001), tumour grade (G1 + G2 vs. G3) (OR = 0.55; p = 0.001) and lymph node metastasis (yes vs. no) (OR = 3.39; p < 0.00001). High STAT3/p-STAT3 expression was correlated with poorer prognosis of ovarian cancer patients for both overall survival (OS) (HR = 1.67, p < 0.00001) and progression-free survival (PFS) (HR = 1.40, p = 0.007). Conclusion The present meta-analysis indicated that high STAT3/p-STAT3 expression is likely predictive of an unfavourable prognosis in ovarian cancer patients. Nonetheless, prospective trials are required to confirm these associations.

A regimen of weekly nab-paclitaxel with weekly carboplatin in recurrent ovarian cancer: A retrospective analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15516-e15516
Author(s):  
Amit Rauthan ◽  
Poonam Patil ◽  
S. P. Somashekhar ◽  
Shabber Zaveri
Keyword(s):  
Ovarian Cancer ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Complete Response ◽  
Recurrent Ovarian Cancer ◽  
Hypersensitivity Reactions ◽  
Free Survival ◽  
Platinum Resistant ◽  
Number Of Patients ◽  
Grade 3

e15516 Background: The standard of care for patients with recurrent platinum resistant ovarian cancer is treatment with non cross-resistant drugs. Carboplatin retreatment is usually not an option in the platinum resistant population. Weekly paclitaxel has been tried in recurrent patients. But paclitaxel can cause hypersensitivity reactions due to its Cremophor based solvent. nab-paclitaxel being a nano-particle albumin bound paclitaxel is devoid of this toxictity. Also, it is thought that nab-paclitaxel may have a higher intratumoral uptake leading to enhanced anti-tumor action. We looked at a regimen using weekly carboplatin with weekly nab-paclitaxel in platinum resistantrelapsed carcinoma ovary who had failed multiple lines of treatment. Methods: We treated 10 patients with recurrent platinum resistant ovarian cancer with measurable disease with nab-paclitaxel 100mg/m2 on days 1,8,15 with carboplatin at AUC 1.5 on days 1,8,15 intravenously, repeated every 28 days for 4 cycles. All patients had received 3 or more lines of chemotherapy for recurrent disease. We looked for response rate, progression free survival and toxicities. Results: Three patients had complete response, 5 patients had partial response and 2 patients had disease progression. Median PFS was 6 months. There were no instances of paclitaxel induced hypersensitivity reactions. Two patients developed grade 3 neutropenia. One patient developed grade 3 thrombocytopenia. Three patients required blood transfusions. One patient developed grade 3 neuropathy. Conclusions: Weekly combination of nab-paclitaxel with weekly carboplatin is a safe and potentially active treatment in recurrent platinum resistant ovarian cancers who had failed multiple lines of treatment. Considering the efficacy and favorable toxicity profile, this weekly combination needs to be tested in a larger number of patients.

The clinical relevance of serum CYFRA 21-1 assay in patients with ovarian cancer

2001 ◽  
Vol 11 (4) ◽  
pp. 277-282 ◽  
Author(s):  
A. Gadducci ◽  
M. Ferdeghini ◽  
S. Cosio ◽  
A. Fanucchi ◽  
R. Cristofani ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Clinical Relevance ◽  
Pathologic Complete Response ◽  
Advanced Ovarian Cancer ◽  
Complete Response ◽  
Figo Stage ◽  
Cox Regression Analysis ◽  
Preoperative Serum ◽  
Response To Chemotherapy

Abstract.Gadducci A, Ferdeghini M, Cosio S, Fanucchi A, Cristofani R, Genazzani AR. The clinical relevance of serum CYFRA 21-1 assay in patients with ovarian cancer.CYFRA 21-1 assay, which detects serum fragments of cytokeratin 19, has been widely assessed as a serum marker of several malignancies. Preoperative serum CYFRA 21-1 levels were retrospectively measured in 60 patients with ovarian cancer and in 59 control patients with benign ovarian disease. CYFRA 21-1 levels were also serially measured in 90 serum samples drawn from patients with advanced (FIGO stage III-IV) ovarian cancer followed after surgery and chemotherapy. Preoperative serum CYFRA 21-1 levels were higher in patients with ovarian cancer compared with controls (median, range = 2.6, 0.1–51.4 ng/ml versus 0.4, 0.0–3.6 ng/ml, P < 0.0001), and among the former, antigen values were higher in the 39 patients with advanced-stage than in the 21 patients with early (FIGO stage I-II) disease (P < 0.0001). In advanced ovarian cancer patients, the 25%, 50%, and 75% quantiles of preoperative CYFRA 21-1 levels were 1.9, 4.8 and 14.4 ng/ml, respectively. Preoperative CYFRA 21-1 levels were lower in the 11 patients who achieved a pathologic complete response at second-look compared with those who had clinically or surgically detectable persistent disease after first-line chemotherapy (median, range 1.9, 0.6–9.2 ng/ml versus 10.2, 0.1–51.4 ng/ml, P = 0.007). The pathologic complete response rate was significantly greater in patients with low preoperative CYFRA 21-1 levels compared with those with elevated CYFRA 21-1 levels at any cut-off limit for the antigen (1.9, 4.8 and 14.4 ng/ml). However, Cox regression analysis failed to detect a significant association between preoperative CYFRA 21-1 assay and survival. As for the follow-up of advanced ovarian cancer patients, CYFRA 21-1 levels were higher in the 42 samples drawn from patients with clinically detectable disease compared with the 48 specimens collected from patients with no clinical evidence of disease (median, range = 1.15, 0.3–40.7 ng/ml versus 0.4, 0.1–9.1 ng/ml, P < 0.0001). In conclusion, preoperative serum CYFRA 21-1 assay appears to be predictive of response to chemotherapy, but not prognostic of survival, for patients with advanced ovarian cancer. Moreover, the serial measurement of CYFRA 21-1 levels might have a potential clinical relevance for the assessment of disease status in patients followed after surgery and chemotherapy.

scholarly journals FBXL7 Upregulation Predicts a Poor Prognosis and Associates with a Possible Mechanism for Paclitaxel Resistance in Ovarian Cancer

2018 ◽  
Vol 7 (10) ◽  
pp. 330 ◽  
Author(s):  
Hui-Wen Chiu ◽  
Jeng-Shou Chang ◽  
Hui-Yu Lin ◽  
Hsun-Hua Lee ◽  
Chia-Hao Kuei ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Poor Prognosis ◽  
Ovarian Cancer Cell ◽  
Pathologic Complete Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Ovarian Cancer Cell Lines ◽  
To Receive

Paclitaxel (PTX) is a common regimen used to treat patients with ovarian cancer. Although approximately 60% of ovarian cancer patients exhibit a pathologic complete response (pCR), approximately 40% of patients appear to be insensitive to PTX adjuvant therapy. Thus, identifying a useful biomarker to predict pCR would be of great help to ovarian cancer patients who decide to receive PTX treatment. We found that FBXL7 was downregulated in OVSAHO (PTX-sensitive) but upregulated in KURAMOCHI (PTX-resistant) cells after PTX treatment at cytotoxic concentrations. Moreover, our data showed that the fold change of FBXL7 expression post-treatment with PTX was causally correlated with the 50% inhibitory concentrations (IC50) of PTX in a panel of ovarian cancer cell lines. In assessments of progression-free survival probability, high levels of FBXL7 transcript strongly predicted a poor prognosis and unfavorable response to PTX-based chemotherapy in patients with ovarian cancer. The knockdown of FBXL7 predominantly enhanced the cytotoxic effectiveness of PTX on the PTX-resistant KURAMOCHI cells. FBXL7 may be a useful biomarker for predicting complete pathologic response in ovarian cancer patients who decide to receive post-operative PTX therapy.

Đánh giá kết quả điều trị bệnh nhân ung thư biểu mô buồng trứng tái phát bằng phác đồ paclitaxel tại Bệnh viện K

2021 ◽  
Author(s):  
Thi Lan Nguyen
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Sensory Nerve ◽  
Progression Free Survival ◽  
Complete Response ◽  
Recurrent Ovarian Cancer ◽  
Initial Therapy ◽  
Ca 125 ◽  
Free Survival ◽  
Platinum Resistant

TÓM TẮT Đặt vấn đề: Ung thư biểu mô buồng trứng (UTBMBT) là bệnh ác tính của tế bào biểu mô buồng trứng. Bệnh có tiên lượng xấu. Mặc dù điều trị ban đầu tối ưu, UTBMBT sẽ tái phát và cần được điều trị. Điều trị UTBMBT tái phát còn gặp nhiều khó khăn. Nghiên cứu này nhằm đánh giá một số đặc điểm lâm sàng, cận lâm sàng UTBMBT tái phát kháng platinum và kết quả điều trị phác đồ paclitaxel nhóm bệnh nhân này. Phương pháp nghiên cứu: Chúng tôi đưa vào nghiên cứu 65 bệnh nhân được điều trị phác đồ paclitaxel cho ung thư biểu mô buồng trứng tái phát khángplatinum, thỏa mãn các tiêu chuẩn lựa chọn và tiêu chuẩn loại trừ. Với phương pháp nghiên cứu mô tả cắt ngang. Kết quả: Các vị trí tái phát thường gặp nhất là hạch (54,3%), phúc mạc (50%), gan (23,9%). Tăng CA125 ở thời điểm tái phát (77,8%) tỷ lệ đáp ứng chung là 22,5%. Tỷ lệ kiểm soát bệnh (bao gồm đáp ứng hoàn toàn, đáp ứng một phần và bệnh giữ nguyên) đạt 62,5%. Trung vị thời gian sống thêm không tiến triển 26,1 tuần (CI 95%: 20,9 - 28,4). Độc tính trên hệ tạo huyết là giảm bạch cầu đa nhân trung tính độ 1,2. Độc tính trên gan 9,3% chủ yếu tăng men gan độ 1,2. Không có độc tính trên thận. Các tác dụng không mong muốn khác như rụng tóc độ 2: 2,7%, viêm miệng gặp ở 2,1% bệnh nhân, thần kinh cảm giác 15%, chỉ gặp ở độ 1. Có mối liên quan giữa đáp ứng điều trị và nồng độ CA 125. Kết luận: Phác đồ paclitaxel sử dụng điều trị UTBMBT tái phát kháng platinum là phác đồ phù hợp về tính hiệu quả và an toàn cho các bệnh nhân UTBMBT đã trải qua phác đồ hóa trị trước đó. ABSTRACT OUTCOMES OFRECURRENT EPITHELIAL OVARIAN CANCER PATIENTS TREATED WITH PACLITAXEL REGIMEN AT K HOSPITAL Introduction: Epithelial ovarian cancer is a malignant abnormality of the epithelial cell of the ovary. The disease has a poor prognosis. Despite optimal initial therapy, the majority of patients will relapse and require further treatment. Treatment of recurrent ovarian cancer is still challenging. This study aims to describe clinical and subclinical characteristics of patients with platinum - resistant relapsed ovarian carcinoma and evaluate the treatment results of the paclitaxel regimen on these patients. Methods: We enrolled 65 patients with platinum - resistant recurrent epithelial ovarian cancer treated with paclitaxel regimen, met the inclusion and exclusion criteria. Results: The most common recurrent sites were lymph nodes (54.3%), peritoneum (50%), and liver (23.9%). CA125 increased at the time of recurrence (77.8%), the overall response rate was 22.5%. Disease control rates (including complete response, partial response, and stable disease) were achieved at 62.5%. Median progression - free survival was 26.1 weeks (95% CI: 20.9 - 28.4). Hematopoietic system toxicities include neutropenia of grade 1, 2. Hepatotoxicity occupied 9.3%, mainly liver enzymes elevation of grade 1, 2. No renal toxicity was observed. Other undesirable effects include hair loss of grade 2 (2.7%), stomatitis(2.1%), sensory nerve 15% but only grade 1. There was a relationship between treatment response and CA 125 levels. Conclusion: The paclitaxel regimen used to treat platinum - resistant recurrent epithelial ovarian cancer is the appropriate regimen in terms of efficacy and safety. After several lines of chemotherapy regimens. Keywords: Recurrent epithelial ovarian cancer, platinum - resistant, paclitaxel.

Phase III Trial of Paclitaxel at Two Dose Levels, the Higher Dose Accompanied by Filgrastim at Two Dose Levels in Platinum-Pretreated Epithelial Ovarian Cancer: An Intergroup Study

2003 ◽  
Vol 21 (15) ◽  
pp. 2843-2848 ◽  
Author(s):  
George A. Omura ◽  
Mark F. Brady ◽  
Katherine Y. Look ◽  
Hervy E. Averette ◽  
James E. Delmore ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Progression Free Survival ◽  
Complete Response ◽  
Recurrent Ovarian Cancer ◽  
Neutropenic Fever ◽  
Dose Effect ◽  
Phase Iii ◽  
High Dose ◽  
Dose Levels

Purpose: To determine if increasing the dose of paclitaxel increases the probability of clinical response, progression-free survival, or overall survival in women who have persistent or recurrent ovarian cancer, and whether doubling the dose of prophylactic filgrastim accompanying the higher paclitaxel dose decreases the frequency of neutropenic fever. Patients and Methods: Consenting patients with persistent, recurrent, or progressing ovarian cancer, despite first-line platinum therapy (but no prior taxane), were randomly assigned to paclitaxel 135 mg/m2, 175 mg/m2, or 250 mg/m2 over 24 hours every 3 weeks. Patients receiving paclitaxel 250 mg/m2 were also randomly assigned to 5 or 10 μg/kg of filgrastim per day subcutaneously. Results: Accession to the paclitaxel 135-mg/m2 arm was closed early. Among the 271 patients on the other regimens with measurable disease, partial and complete response on paclitaxel 250 mg/m2 (36%) was significantly higher than on 175 mg/m2 (27%, P = .027). This difference was more evident among patients who never responded to prior platinum. However, progression-free and overall survival results were similar. The median durations of overall survival were 13.1 and 12.3 months for paclitaxel 175 mg/m2 and 250 mg/m2, respectively. Thrombocytopenia, neuropathy, and myalgia were greater with paclitaxel 250 mg/m2 (P < .05). The incidence of neutropenic fever after the first cycle of paclitaxel 250 mg/m2 was 19% and 18% on the 5-μg/kg and 10-μg/kg filgrastim dose, respectively (22% for paclitaxel 175 mg/m2 without filgrastim). Conclusion: Paclitaxel exhibits a dose effect with regard to response rate, but there is more toxicity and no survival benefit to justify paclitaxel 250 mg/m2 plus filgrastim. Doubling the filgrastim dose from 5 to 10 μg/kg did not reduce the probability of neutropenic fever after high-dose paclitaxel.

Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer: A Randomized Multicenter Phase II Trial of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group

2011 ◽  
Vol 29 (2) ◽  
pp. 242-248 ◽  
Author(s):  
Jalid Sehouli ◽  
Dirk Stengel ◽  
Philipp Harter ◽  
Christian Kurzeder ◽  
Antje Belau ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Treatment Option ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Complete Response ◽  
Recurrent Ovarian Cancer ◽  
German Society ◽  
Platinum Resistant

PurposeWeekly administration of topotecan (Tw) is less toxic and widely considered a better treatment option than conventional 5-day therapy (Tc) in women with platinum-resistant recurrent ovarian cancer. We conducted a randomized phase II trial (TOWER [Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer]) to better define the ratio between benefits and risks with either treatment approach.Patients and MethodsPatients were randomly assigned to two independent two-stage protocols of Tw (4 mg/m2/wk administered on days 1, 8, and 15) or Tc (1.25 mg/m2/d on days 1 to 5). We evaluated risk ratios (RRs) for the primary end point of clinical benefit (complete response, partial response, and stable disease), the duration of progression-free survival (PFS) and overall survival (OS), associated hazard ratios (HRs), and RRs of toxicity with 95% CIs.ResultsIn total, 194 patients were randomly assigned at 54 centers to Tw (n = 97) or Tc (n = 97). Clinical benefit was observed in 36 of 76 (47%; 95% CI, 36% to 59%) Tw and 46 of 80 (58%; 95% CI, 46% to 68%) Tc patients (RR, 1.21; 95% CI, 0.90 to 1.64; P = .205). Patients in the Tw group had a slightly shorter PFS (HR, 1.29; 95% CI, 0.96 to 1.76) but similar OS (HR, 1.04; 95% CI, 0.74 to 1.45) compared with Tc. Tw was associated with significantly lower risks of anemia (RR, 0.35; 95% CI, 0.16 to 0.79), neutropenia (RR, 0.38; 95% CI, 0.23 to 0.65), and thrombocytopenia (RR, 0.23; 95% CI, 0.09 to 0.57).ConclusionWith regard to effectiveness in terms of response and PFS, Tc remains the standard of care in patients with platinum-resistant recurrent ovarian cancer. However, comparable OS rates and a favorable toxicity profile make Tw another viable treatment option in this setting.

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