Three-Day Topotecan Schedule in Heavily Pretreated Recurrent Ovarian Cancer Patients

2009 ◽  
Vol 19 (3) ◽  
pp. 455-459
Author(s):  
Marco Calcagno ◽  
Filippo Bellati ◽  
Innocenza Palaia ◽  
Francesco Plotti ◽  
Stefano Basile ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Stable Disease ◽  
Clinical Benefit ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Recurrent Ovarian Cancer ◽  
Ca 125 ◽  
Prior Chemotherapy ◽  
Heavily Pretreated

Objective:To evaluate the clinical benefit of a 3-day topotecan schedule in heavily pretreated recurrent ovarian cancer patients scheduled for palliative treatment.Methods:Eligibility criteria were 2 or more prior chemotherapy regimens, Eastern Cooperative Oncology Group performance status of 2 or less; adequate organ function, assessable disease by serum CA-125 measurement before each cycle; and 1 or more cycle of topotecan (1.5 mg/m2per day) on 3 consecutive days of a 28-day treatment cycle. Toxicity was graded according to the National Cancer Institute Common Toxicity Criteria version 3. Tumor response, stable disease, and progression were evaluated on the basis of CA-125 levels.Results:A total of 68 patients were considered eligible for the study. Median age was 58 years (range, 40-77 years), and the median number of prior chemotherapy regimens was 2 (range, 2-6). A total of 272 cycles of topotecan were administered, with a median of 4 cycles per patient (range, 1-8). No treatment delays or dose reduction was recorded. Major toxicities were grade 3/4 (18%) neutropenia, neutropenic fever (6%), grade 4 thrombocytopenia (3%), requirements for blood (5%), and platelet transfusions (3%). Thirty-five (54%) of the 64 evaluable patients showed a clinical benefit. Of these, 11 patients (17%) had a partial response, and 24 (37%) had stable disease with a median time to progression of 7.5 months (range, 6-10 months) and 4 months (range, 2-6 months), respectively.Conclusion:More than half of heavily pretreated ovarian cancer patients may benefit from 3-day topotecan.

Phase II study on the combination carboplatin-celecoxib in heavily pre-treated recurrent ovarian carcinoma patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15009-15009
Author(s):  
F. Legge ◽  
V. Salutari ◽  
A. Paglia ◽  
A. Testa ◽  
D. Lorusso ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Recurrent Ovarian Cancer ◽  
Platinum Resistant ◽  
Response To Chemotherapy ◽  
Short Period ◽  
Heavily Pretreated ◽  
Cox 2

15009 Background: Cyclooxygenase-2 (COX-2) has been shown to be involved in several steps of ovarian onset and progression and its overepression is associated with a poor chance of response to chemotherapy and poor prognosis in ovarian cancer. Celecoxib, an orally active selective COX-2 inhibitor, has been tested for its ability to potentiate the activity of carboplatin in treatment of heavily pretreated recurrent ovarian cancer patients. Methods: A phase II study was planned, considering the regimen active if at least 12 responses were observed among the 43 enrolled patients. Celecoxib (400 mg/die), and carboplatin (5 AUC) q28 were administered, until progression or unacceptable toxicity. Response was assessed by RECIST and also by Rustin criteria. Results: 34 pts (median age: 60 yrs, range 28–74) and an ECOG performance status (0/1/2) of (21/12/1), were enrolled. 58.8% of patients were platinum resistant (progressing during or < 6 months from primary treatment). Median number of previous chemotherapy regimens was 3 (range 2–6). Currently 27 patients are evaluable for response. The overall response rate (CR and PR) was 25.9% (2 CR, 5 PR) with stabilization of disease in 8 patients (29.6%). Four responses occurred in platinum sensitive and 3 in platinum resistant group Median time to response was 11 weeks (range 9–19) and median duration of response was 23 weeks (range 12–39). According to Rustin criteria 10 patients out of 25 (40%) were considered responsive to treatment (return of CA125 levels to normal level or >50% reduction). Overall, 143 cycles were administered with a median value of 3 cycles (range = 1–10). Moderate/severe toxicities were as follows: G3 anemia occurred in 2.3% cycles, G3 neutropenia in 4.6% cycles, G3 thrombocytopenia in 1.5% cycles, G3/4 gastrointestinal toxicity occurred in 4.6% cycles. Cutaneous diffuse erithema was observed in 2 patients, in both cases recovered with a short period of antihistaminic treatment; 2 cases of hypertension were documented, G2 hypersensitivity reactions during carboplatin infusion were observed in 4 cases. Conclusions: Celecoxib combined with carboplatin is well tolerated and has promising activity as salvage treatment in heavily pretreated recurrent ovarian cancer patients. No significant financial relationships to disclose.

scholarly journals Prediction of tumour response induced by chemotherapy using modelling of CA-125 kinetics in recurrent ovarian cancer patients

2014 ◽  
Vol 110 (6) ◽  
pp. 1517-1524 ◽  
Author(s):  
M Wilbaux ◽  
E Hénin ◽  
A Oza ◽  
O Colomban ◽  
E Pujade-Lauraine ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Tumour Response ◽  
Recurrent Ovarian Cancer ◽  
Ca 125

Effects of weekly bevacizumab and pegylated liposomal doxorubicin in heavily pretreated patients with recurrent or progressed ovarian cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5547-5547
Author(s):  
Y. Kikuchi ◽  
H. Kouta ◽  
R. Kikuchi ◽  
M. Takano ◽  
T. Kita ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Liposomal Doxorubicin ◽  
Treatment Options ◽  
Evaluation Criteria ◽  
Pegylated Liposomal Doxorubicin ◽  
Recurrent Ovarian Cancer ◽  
Cytotoxic Agents ◽  
Ca 125 ◽  
Heavily Pretreated ◽  
Pretreated Patients

5547 Background: Vascular endothelial growth factor (VEGF) plays a central role in tumor angiogenesis and is regarded a promising therapeutic target. Bevacizumab (A) has significant antitumor activity in combination with cytotoxic agents. Currently, pegylated liposomal doxorubicin (D) is provided as one of the standard treatment options in recurrent ovarian cancer. Thus, we attempted to determine effects in combination of A and D for heavily pretreated patients with recurrent or progressed ovarian cancer. Methods: Twenty-two patients with heavily pretreated (more than one regimen or more than 6 cycles by paclitaxerl and carboplatin) received at least more than 3 cycles of weekly A-D consisting of A: 2 mg/kg and D: 10 mg/m2 (3 weeks, one week rest). The primary endpoint was response according to CA 125 and response evaluation criteria in solid tumor (RECIST) criteria. Results: Of 22 patients evaluable for CA 125 response, 7 (32%) had a response (decrease of >50%), and 8 (36%) patients had not progressed (doubling of CA 125) following 6 months on treatment. In RECIST evaluation, 2 (9%) patients had complete remission (CR) and 6 (27%) had partial remission (PR), resulting in 55% clinical benefit rate (CBR). Progression free interval (PFI) showed more than 6 months. Any hematological adverse effect was not observed in the present study. Gastrointestinal perforation was observed in only one case and was conservatively treated. Although nasal bleeding was frequently observed, no treatment was required. A induced hypertension was also observed and manageable. Hand-foot syndrome seemed due to D was seen in 3 of 22 patients and treatment was required in only one case. Conclusions: B seemed to enhance effect of D. This is the first study of weekly A-D in heavily pretreated ovarian cancer patients. Weekly A-D warrants further clinical study in such clinical settings. No significant financial relationships to disclose.

Survival and clinical outcomes of ovarian cancer patients enrolled in phase I clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5559-5559
Author(s):  
Bradley Corr ◽  
Marisa Moroney ◽  
Jeanelle Sheeder ◽  
Brandon Sawyer ◽  
S. Gail Eckhardt ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ovarian Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Ca 125 ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Heavily Pretreated

5559 Background: Ovarian cancer patients who enroll in Phase I clinical trials are typically platinum resistant, heavily pretreated patients with a poor prognosis. Historically, clinical benefit of Phase I trials in this patient population has been uncertain. We assessed prognostic factors and survival in women with recurrent, previously treated ovarian cancer who enrolled in Phase I clinical trials. Methods: We performed a retrospective analysis of all ovarian cancer patients who were treated on Phase I clinical trials from 2008 through 2018 at the University of Colorado Cancer Center. Patient characteristics, treatment-related toxicities and survival data were assessed. Descriptive statistics and Cox proportional hazards models were utilized to identify risk factors associated with survival time. Results: A total of 132 individual patients were treated on Phase I clinical trials. Patients had a median age of 59 years (range 33-88) with a median of 5.5 (range 1-13) previous chemotherapy lines. 53/132 (40%) of patients were treated on multiple Phase I trials with a median of 1 (range 0-5) prior Phase 1 clinical trial enrollments. All patients had an ECOG performance status of 0 or 1. Overall response rate (defined as complete or partial response) was 9% and disease control rate (defined as complete or partial response or stable disease as best response) was 33%. Median overall survival (OS) was 11.5 months (95% CI: 9.3-13.7). Two patients died on trial due to progression of disease while no patients died due to treatment-related toxicity. In multivariate analysis, independent risk factors predicting shorter survival were elevated CA-125 (HR 2.8; 95% CI: 1.6-5.2) and albumin < 3.5 g/dL (HR 2.5; 95% CI: 1.65-3.79). BMI > 25 predicted longer survival (HR 0.65; 95% CI: 0.44-0.96). Conclusions: Phase I clinical trials for heavily pretreated ovarian cancer patients are safe by a standard of no patients experiencing toxicity-related deaths in our study. They are clinically efficacious with patients experiencing OS of 11.5 months, which is comparable to existing approved therapies. Elevated CA-125 and low albumin levels predict shorter survival, while BMI > 25 predicts longer survival. Phase I clinical trial options should be considered for all heavily pretreated ovarian cancer patients if available to them.

Preliminary results of anlotinib and niraparib dual therapy evaluation in platinum-resistant recurrent ovarian cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17532-e17532
Author(s):  
Guochen Liu ◽  
Jihong Liu ◽  
Bingna Xian ◽  
Jing Li ◽  
Yanling Feng ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Adverse Events ◽  
Skin Reaction ◽  
Group Performance ◽  
Antiangiogenic Therapy ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Recurrent Ovarian Cancer ◽  
Platinum Resistant ◽  
Hand Foot Skin Reaction

e17532 Background: Patients with platinum-resistant ovarian cancer have a poor prognosis. Effective treatment options for these patients are limited. Combination of PARP inhibitors and antiangiogenic therapy is reported as an effective antitumor strategy. In this study (ANNIE), we evaluate the activity of niraparib combined with anlotinib in patients with platinum resistant recurrent ovarian carcinoma. Methods: The ANNIE trial (ClinicalTrials.gov identifier NCT04376073) was a multicentre, single-arm, phase 2 study that evaluated the safety and activity of niraparib combined with anlotinib in patients (≥18 & ≤70 years, an Eastern Cooperative Oncology Group performance status of 0 or 1) with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer cancer whose disease recurred in less than 6 months after the last administered platinum therapy, and with measurable disease according to the Response Evaluation Criteria in Solid Tumors. Patients received oral niraparib 300mg/200mg once daily continuously and anlotinib 12mg (The initial dose was reduced to 10mg on November 1, 2020) on day 1-14 of each 21-day cycle thereafter until disease progression or intolerable toxicity. The primary objective was to assess objective response rate (ORR; complete plus partial responses) according to RECIST version 1.1. 40 cases are planned to be enrolled. Results: Between May 22, 2020 and February 6, 2021, we enrolled 33 patients (median age, 56 years [range, 37-69 years]). Patients had received a median of six (range, 2-9) previous lines of therapy. The cut-off date of analysis was February 4, 2021, the median follow-up was 4.1 months (range, 0.1–8.1). At data cutoff, all but seven (2 voluntarily withdrew, 5 with progressive disease) of the patients were still on treatment. Twenty-five patients underwent imaging evaluation. The confirmed best overall response assessment showed 12 with partial responses, 12 with stable disease, yielding the ORR of 48.0% (95% CI, 27.0%̃69.0%). The median duration of response and the median PFS were not reached. Drug-related grade 3 or worse treatment-emergent adverse events were occurred in 39.4% patients, including hand-foot skin reaction (3 pts), thrombocytopenia (2 pts), hypertriglyceridemia (2 pts), neutropenia (2 pts), anemia (1 pts) and hypertension (1 pts). The most common treatment emergent adverse events were hand-foot skin reaction (36.4%), hypertension (36.4%), and thrombocytopenia (33.3%). No treatment-related death was recorded. Enrollment was ongoing so far. Conclusions: Niraparib in combination with anlotinib showed promising antitumor activity and tolerable toxicity in patients with platinum resistant recurrent ovarian cancer. The conclusion can be clarified after the research is completed. Clinical trial information: NCT04376073.

Topotecan therapy as salvage in heavily pretreated ovarian cancer patients (hpocp)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15057-15057
Author(s):  
G. B. Wcislo ◽  
L. Bodnar ◽  
A. Nasilowska ◽  
K. Szarlej-Wcislo ◽  
C. Szczylik
Keyword(s):  
Ovarian Cancer ◽  
Fatal Outcome ◽  
Ca 125 ◽  
Clinical Response Rate ◽  
Hematologic Toxicity ◽  
Toxicity Profile ◽  
Prior Chemotherapy ◽  
Platinum Sensitive ◽  
Chemotherapy Agent ◽  
Heavily Pretreated

15057 Background: Topotecan is utilized as to a second-line chemotherapy agent in ovarian cancer. The third or more line of chemotherapy is possibly to use against ovarian cancer which is chemosensitive even when this malignancy progressed. Methods: Prior chemotherapy with platinum compounds, paclitaxel, doxorubicin was used. Topotecan was given as 30-minute infusion at the dose of 1.5 mg/m2 through 5 consecutive days every 21 days. Toxicity profile was assessed according to NCI CTC and response was measured while met RECIST and CA-125 criteria described by Rustin et al. Results: Between 2001 and 2005, 22 hpocop were enrolled onto the study and received at least two cycles of topotecan salvage, median 6 (range 2–6). The patients were previously treated with chemotherapy and characterised 37% (8/22) as platinum-sensitive, 9% (2/22) as partial platinum- sensitive, 27% (6/22) as platinum-resistant and 27% (6/22) as platinum-refractory. Twenty hpocp of the total number of 22 were monitored after chemotherapy through fulfilling RECIST criteria: 7/20 (35%) -PR, 7/20 (35%)-NC, 8/20 (40%)-PD. The clinical response rate in 20 patients with assessable CA 125 levels was 30% (6/20) with 75% response, and 15% (3/20) with 50% response by Rustin et al. criteria. Time to progression of ovarian cancer was median 5,0 months, SD ± 2.0 (range from 2 to 7) and median survival 8 months, SD ± 21 (range from 2 to 39). Toxicity profile was recorded as following: neutropenia 3/4th grade in 8/22 (36%), anaemia 3/4th grade in 9/22 (41%), thrombocytopenia 4th grade in 6/22 (27%), and non-hematologic toxicity relied on alopecia 7/22 (32%). We have not observed fatal outcome after topo salvage therapy. Conclusions: Topotecan could be involved in therapy of patients with ovarian cancer previously heavily pretreated. It offers clinical benefits in ovarian cancer course as to be a stabilised disease despite prior chemotherapy but reliable management alleviates hematologic toxicity. No significant financial relationships to disclose.

A multi-institutional evaluation of the safety and efficacy of bevacizumab for recurrent, platinum-resistant ovarian cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5019-5019 ◽  
Author(s):  
J. D. Wright ◽  
A. Alvarezsecord ◽  
T. M. Numnum ◽  
R. P. Rocconi ◽  
M. A. Powell ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Stable Disease ◽  
Bowel Perforation ◽  
Single Agent ◽  
Recurrent Ovarian Cancer ◽  
Significant Activity ◽  
Recent Trial ◽  
Platinum Resistant ◽  
Heavily Pretreated ◽  
Grade 3

5019 Background: Bevacizumab has shown activity in recurrent ovarian cancer with an acceptable adverse event profile. However, the incidence of bowel perforation in a recent trial of heavily pretreated ovarian cancer patients was higher than expected from prior experience with bevacizumab. Whether the difference in the rate of bowel perforation was due to refractory disease, treatment history, disease burden, or location of tumor is uncertain. We sought to review our multi-institutional experience with bevacizumab in patients with recurrent ovarian cancer. Methods: A retrospective review of patients with recurrent ovarian cancer treated with single agent or combination bevacizumab therapy was undertaken. Toxicity was assessed using standard criteria. Response was determined radiographically and through serial CA125 measurements. Statistical analysis to determine factors associated with toxicity and response was performed. Results: Sixty-two eligible patients were identified. All had failed prior platinum-based therapy and had received a median of 5 prior chemotherapy regimens and 2 prior platinum-containing regimens. Single agent bevacizumab was administered to 12 (19%) women, while 50 (81%) received the drug in combination with a cytotoxic agent. The most common toxicities were myelosuppression (60%), proteinuria (19%) and hypertension (16%). Grade 3–5 toxicities occurred in 15 (24%) patients, including grade 3–4 hypertension in 4 (7%). Gastrointestinal perforations were identified in 4 (7%) subjects. Nine (15%) patients discontinued therapy due to toxicity. Fifty-eight patients were assessable for response. The overall response rate was 36% (4 CR, 17 PR) with stable disease in 40%. Clinical benefit (CR, PR, stable disease) was seen in 83% of patients treated with single agent therapy and 74% of those treated with bevacizumab-combination regimens. Conclusions: Bevacizumab demonstrates significant activity for recurrent, platinum-resistant ovarian cancer. Life threatening bowel perforations were noted in 7% of our subjects. The frequency of perforations in our cohort suggests that this complication is more likely to occur in heavily pretreated patients. No significant financial relationships to disclose.

The clinical benefit of cisplatin-doxorubicin combination in heavily pretreated ovarian cancer patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15052-15052
Author(s):  
M. Steiner ◽  
O. Lavie ◽  
M. Leviov ◽  
Z. Shklar ◽  
A. Rabkin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Cancer Patients ◽  
Clinical Benefit ◽  
Complete Response ◽  
Second Line ◽  
Platinum Resistant ◽  
Heavily Pretreated ◽  
Line Of Therapy

15052 Background: Cispatin-doxorubicin (Adriamycin) combination (50 mg/m2 each every 3 weeks) was used to treat ovarian cancer patients after failure of various chemotherapy lines. Methods: Eighteen patients were treated. Their mean age was 59 years (median 57.8, 41.3–70.3). They all had post operative first line carboplatin combination therapy (77% taxol containing) and all achieved NED status at end of therapy. They relapsed within 1–74 months from end of carboplatin therapy (median 9.5, mean 14.1). 3/13 patients (23%) were platinum resistant relapsing within less than six months. Second line therapy included carboplatin retreatment in 8/18 patients (44.5%) - (combined with taxol in 5 and as single agent in 3 patients). All patients received Topotecan therapy, 8 as second line, 6 as third line and 4 as forth line of therapy. Cis platin - Adriamycin combination was used as 3rd to 6th line of therapy (median 4th). All patients were in good general condition with normal renal function and had clinical evidence of recurrent disease confirmed by clinical examination and/or CT scan and CA125 level. 6/18 patients (33.3%) had severe symptoms of disease, 6/18 (33.3%) mild to moderate symptoms and 6/18 (33.3%) were asymptomatic. Results: 3–11 cycles of therapy were administered (median 7) using 60–100% of planned dose (median 100). Treatment was generally well tolerated with Grade III toxicity in 4/18 patients (22.2%) - (myelotoxicity in 2 and asthenia in 2 patients). 4/18 patients (22.2%) reported quality of life improvement, 4/18 (22.2%) reported quality of life deterioration and 10/18 (65.6%) stable quality of life during therapy. 13/18 patients (72.2%) benefited from therapy. 5/18 (27.7%) achieved complete response, 3/18 (16.8%) partial response and 5/18 (27.7%) minimal response or disease stabilization. All three platinum resistant patients responded: two achieved complete response and one minimal response. Mean time to progression in all responding patients was 9.4 months (median 8.6, 2.6–16.5). Conclusions: We concluded that Cis-Platin - Adriamycin combination is still effective in heavily pretreated ovarian cancer patients and clinical benefit can be achieved with reasonable toxicity. The combination can be considered an additional treatment option. No significant financial relationships to disclose.

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