scholarly journals The efficacy and safety of niraparib for ovarian cancer: a single-center observational study from China

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Jing Ni ◽  
Xianzhong Cheng ◽  
Qian Zhao ◽  
Zhiqin Dai ◽  
Xia Xu ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Partial Response ◽  
Adverse Events ◽  
Cancer Patients ◽  
Real World ◽  
Parp Inhibitor ◽  
Objective Response ◽  
Single Center ◽  
Real World Data ◽  
Platinum Based Chemotherapy

Abstract Background Niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, is approved for first/second-line maintenance treatment of ovarian cancer patients with complete or partial response to platinum-based chemotherapy, and multi-line monotherapy in BRCAmt patients or platinum-sensitive recurrence patients with homologous recombination deficiency (HRD). We present real-world experience from a single center of China. Methods Patients treated with niraparib in Jiangsu Cancer Hospital between June 2019 to July 2020 were recruited. The initial dose was given according to individualization. Response and adverse events (AEs) were analyzed by Response Evaluation Criteria in Solid Tumors v1.1. and National Cancer Institute Common Terminology Criteria for Adverse Events v5.0, respectively. HRD testing (AmoyDx®) was detected in most patients. Treatment was given until unequivocal progression or intolerable toxicity. Results Twenty-two patients all received niraparib at a bolus of 200 mg/d. Fifty percent of patients with high-grade serous ovarian cancer are HRD-positive. Six patients underwent first-line maintenance therapy. Sixteen patients received exploratory therapy. Ultimately image evaluation revealed that two patients achieved partial response (PR) and one patient achieved stable disease (SD), yielding objective response rate (ORR) of 33.3% (95%CI = 0.060–0.759) and disease control rate (DCR) of 50% (95%CI = 0.140–0.861) in the exploratory multi-line monotherapy group. The most common AEs were nausea, thrombocytopenia, and anemia. Grade 3–4 thrombocytopenia were managed by dose reduction and interruption. Leg swelling was observed as a new adverse event. Conclusion It is feasible that patients receiving a bolus of 200 mg/d in patients from Chinese population can acquire promising efficacy and tolerance. This is the first real-world data about niraparib in ovarian cancer patients with available HRD status from China.

scholarly journals The Efficacy and Safety of Niraparib for Advanced Ovarian Cancer: A Single-center Observational Study From China

2020 ◽  
Author(s):  
Jing Ni ◽  
Xianzhong Cheng ◽  
Qian Zhao ◽  
Zhiqin Dai ◽  
Xia Xu ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Partial Response ◽  
Adverse Events ◽  
Cancer Patients ◽  
Real World ◽  
Parp Inhibitor ◽  
Objective Response ◽  
Advanced Ovarian Cancer ◽  
Real World Data ◽  
Platinum Based Chemotherapy

Abstract BackgroundNiraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, is approved for first/second-line maintenance treatment of ovarian cancer patients with complete or partial response to platinum-based chemotherapy, and multi-line monotherapy in BRCAmt patients or platinum-sensitive recurrence patients with homologous recombination deficiency (HRD) positive. We present real-world experience from China. MethodsPatients with niraparib in Jiangsu Cancer Hospital between June 2019 to July 2020 were recruited. The initial dose was given according to individualization. Response and adverse events (AEs) were analyzed by Response Evaluation Criteria in Solid Tumors v1.1. and National Cancer Institute Common Terminology Criteria for Adverse Events v5.0, respectively. HRD testing (AmoyDx®) was detected in most patients. Treatment was given until unequivocal progression or intolerable toxicity. ResultsTwenty-two patients all received niraparib at an bolus of 200mg/d. 50% of patients with high-grade serous ovarian cancer are HRD-positive. Six patients underwent first-line maintenance therapy. Sixteen patients received exploratory therapy. Ultimately image evaluation revealed that two patients achieved partial response (PR) and one patient achieved stable disease (SD), yielding objective response rate (ORR) of 33.3% (95%CI=0.060-0.759) and DCR of 50% (95%CI=0.140-0.861) in the exploratory multi-line monotherapy group. Commonly AEs were nausea, thrombocytopenia, and anemia. Grade 3-4 thrombocytopenia were managed by dose reduction and interruption. Leg swelling was observed as a new adverse event. ConclusionIt is feasible for patients received a bolus of 200mg/d in Chinese population with promising efficacy and well tolerated. This is first real world data about niraparib in ovarian cancer patients with HRD status from China.

scholarly journals Real-world adverse events with niraparib 200 mg/day maintenance therapy in ovarian cancer: a retrospective study

2019 ◽  
Vol 15 (36) ◽  
pp. 4197-4206
Author(s):  
Jack R Gallagher ◽  
Kylee Jean Heap ◽  
Susan Carroll ◽  
Karin Travers ◽  
Brooke Harrow ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Clinical Trial ◽  
Retrospective Study ◽  
Adverse Events ◽  
Real World ◽  
Recurrent Ovarian Cancer ◽  
Medical Record Data ◽  
Platinum Based Chemotherapy ◽  
Record Data ◽  
Grade 3

Aim: To assess real-world occurrence of common clinical trial-reported adverse events (AE) among patients with recurrent ovarian cancer initiating niraparib 200 mg/day. Materials & methods: This retrospective observational study used physician-extracted anonymized medical record data of eligible patients initiating niraparib 200 mg/day after platinum-based chemotherapy. Results: Of 153 patients, 57 (37%) experienced ≥1 of the three most common all-grade AEs within 3 months after niraparib initiation: nausea (16%; grade 3/4: 2%), thrombocytopenia (14%; grade 3/4: 3%) and fatigue (24%; grade 3/4: 3%). In the ENGOT-OV16/NOVA trial, these respective AEs occurred in 74, 61 and 59% of patients. Conclusion: Incidence of common clinical trial-reported AEs was lower among patients initiating niraparib 200 mg/day in real-world practice versus patients initiating niraparib 300 mg/day in ENGOT-OV16/NOVA.

Prospective, multicenter, noninterventional and registry clinical study of apatinib in patients with advanced gastric cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 137-137 ◽  
Author(s):  
Chunmei Bai ◽  
Diansheng Zhong ◽  
Ruixing Zhang ◽  
Xiubao Ren ◽  
Likun Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Real World ◽  
Objective Response ◽  
Progression Free Survival ◽  
Similar Efficacy ◽  
Phase Iii ◽  
Efficacy Evaluation ◽  
Real World Data ◽  
Skin Reactions

137 Background: The aim of this study was to observe the safety of apatinib in the real world with wider inclusion criteria. The efficacy of apatinib was evaluated including overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR). Methods: This trial enrolled patients from 32 centers in china with advanced gastric adenocarcinoma who had progressed after undergoing at least two lines of systemic chemotherapy, or patients who were considered to benefit from the treatment. We recommended starting from oral administration of 500mg qd, 28 days for a cycle. Dose could be appropriately adjusted according to the patients’ physical condition. Results: Between March 2015 and September 2017, 326 patients were enrolled. The average age was 62 years old, and the ratio of male to female was about 2:1. Patients received perioperative, first-line, second-line, and third-line or more treatment were 1,39,69 and 217 people respectively. There were 192 patients received efficacy evaluation, 9 patients achieved partial response(PR), 125 had disease stability(SD). The ORR and DCR were 4.6% and 69.8% respectively. The median PFS and median OS were 3.7 months and 7.3 months respectively. In the 326 patients, there were 153 patients with initial dose of 500 mg, 3 and 55 patients achieved PR and SD, respectively. The ORR and DCR were 3.3% and 63.7%, respectively. The median PFS and median OS were 3.5 months and 8.4 months, respectively. There were 237 patients in all 326 patients received safety analysis. Common adverse events were hypertension (57%), hand-foot skin reactions (26.6%), fatigue (29.5%), proteinuria (19.0%), bleeding (10.1%) and diarrhea (8.0%). The grade 3 to 4 adverse events were hypertension (6.3%), hand-foot skin reactions (3.8%), proteinuria(3.0%) and bleeding (2.1%). Conclusions: This real-world data in which more patients were given apatinib 500mg or less qd showed similar efficacy to Phase III clinical trial (850mg qd).The incidence of adverse events was consistent with that of Phase III clinical data,there was no new adverse events had been seen. Clinical trial information: NCT02668380.

Correlation of patient characteristics with clinical outcomes of camrelizumab combined with apatinib for unresectable hepatocellular carcinma (uHCC): An observational retrospective analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16120-e16120
Author(s):  
Gang Liu ◽  
Liansheng Gong ◽  
Wenxuan Zhou ◽  
Xiaoli Li ◽  
Fei Wang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Subgroup Analysis ◽  
Therapeutic Efficacy ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Therapeutic Effects ◽  
First Line ◽  
Real World Data ◽  
Baseline Serum

e16120 Background: There is limited data on clinical parameters to evaluate the therapeutic effects on immune checkpoint inhibitors (ICIs) combined with anti-angiogenic agent for uHCC. Here, we assessed efficacy and safety of camrelizumab combined with apatinib for uHCC from real-world data, and performed the retrospective subgroup analysis to investigate the potential factors related to therapy response and patients survival as well. Methods: We evaluated clinical data and outcome of 26 uHCC patients who received camrelizumab 200 mg intravenously every 2 weeks combined with apatinib 250 mg qd between May 2019 and Jul 2020. Objective response rate (ORR), disease control rate (DCR), progression free survival (PFS) and overall survival (OS) were evaluated using independent central review mRECIST and RECIST 1.1. Treatment related adverse events (TRAEs) and immune-related adverse events (irAEs) were evaluated. Results: The patients’ characteristics of our cohort are summarized in Table. Overall, our study shows that ORR was 57.7% (mRECIST), DCR was 84.62% (mRECIST), median PFS (mPFS) and OS (mOS) were 11 months and 18.2 months, respectively. For subgroup analysis, patients with first-line therapy (n=22) had dramatically better mPFS than non-first-line (15.0 vs. 4 months; p=0.01). Patients with baseline serum alpha-foetoprotein (AFP) > 400 ng/ml shows better therapeutic efficacy ( p<0.001). The patients with decreased AFP level after treatment had significantly longer mPFS (15.0 vs. 4 months; p<0.001) and mOS (NR vs. 5.7 months; p<0.001) than others. Overall, 14 (53.85%) patients had grade≥3 TRAEs, only 3 (11.54%) patients had grade≥2 irAEs. Conclusions: The first up-to-date real-world evidence indicates that both the baseline and post-treatment AFP level might be independent prognostic factors to evaluate the therapeutic efficacy and clinical outcome on the combination therapy of camrelizumab and apatinib. While larger sample sizes and longer follow-up study are needed to verify reliability of statistical results.[Table: see text]

Room for growth: Real-world maintenance and treatment PARP inhibitor use in BRCAm ovarian cancer patients

2021 ◽  
Vol 162 ◽  
pp. S268-S269
Author(s):  
Sarah Lee ◽  
Maria Smith ◽  
Gianina Monestime ◽  
Bhavana Pothuri
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Real World ◽  
Parp Inhibitor

scholarly journals Results of a phase II clinical trial of 6-mercaptopurine (6MP) and methotrexate in patients with BRCA-defective tumours

2019 ◽  
Vol 122 (4) ◽  
pp. 483-490 ◽  
Author(s):  
Corran Roberts ◽  
Victoria Y. Strauss ◽  
Sylwia Kopijasz ◽  
Charlie Gourley ◽  
Marcia Hall ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Parp Inhibitor ◽  
Objective Response ◽  
Acquired Resistance ◽  
Xenograft Model ◽  
Progression Free Survival ◽  
Breast Cancer Patients

Abstract Background Tumour cells with BRCA1/2 gene mutations demonstrate increased sensitivity to platinum and poly (ADP-ribose) polymerase (PARP) inhibitors. 6-mercaptopurine (6MP) was found to selectively kill BRCA-defective cells in a xenograft model as effectively as the PARP inhibitor AG014699, even after these cells acquired resistance to a PARP inhibitor or cisplatin. Methods This phase II single-arm trial investigated the activity of 6MP 55–75 mg/m2 per day, and methotrexate 15–20 mg/m2 per week in advanced breast or platinum-resistant ovarian cancer patients with a BRCA1/2 germline mutation, who had progressed after ≥1 previous line of chemotherapy. The primary outcome was objective response including stable disease (SD) as an assessment of clinical benefit rate (CBR), at 8 weeks, by RECIST v1.1. Secondary outcomes included overall survival (OS) and progression-free survival (PFS). Results In total, 67 evaluable patients were recruited; 55 ovarian and 11 breast cancer patients. In total, 21 patients had SD (31%), one had a partial response (1.5%); CBR was 33% at 8 weeks. In total, 12/67 patients (18%) had SD at 16 weeks. In total, five ovarian cancer patients had SD for over 200 days. Median OS was 10.3 months (95% CI 6.9–14.5), median PFS 1.9 months (1.7–2.8). Conclusions The overall activity of 6MP and methotrexate in these patients was low; however, there was a small group of patients who appeared to derive longer-term clinical benefit. Trial registration NCT01432145 http://www.ClinicalTrials.gov.

Breast cancer patients’ quality of life: Real-world data.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23115-e23115
Author(s):  
Paris A. Kosmidis ◽  
Barbara Athanasakou ◽  
Thanos Kosmidis
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Real World ◽  
Breast Cancer Patients ◽  
Real World Data ◽  
Security Controls ◽  
Real World Evidence ◽  
Systemic Treatments ◽  
Platinum Based Chemotherapy

e23115 Background: CareAcross is a digital platform dedicated to support, inform and engage with cancer patients. It also collects medical and other data, and generates real world evidence. Methods: In an effort to collect and analyze information from breast cancer patients regarding side effects in relation to their treatments and supplements intake, we contacted 4837 patients in the UK, Germany, France, Spain and Italy. 474 had triple negative breast cancer (TNBC) and the remaining 4363 other breast cancer subtypes (non-TNBC). All data was collected anonymously, with strong privacy and security controls. Results: Different regimens were given either as adjuvant or as systemic treatments. AC treatment was given to 9% of TNBC vs 4% of non-TNBC patients; FEC-T to 20% vs 13%, FEC to 10% vs 8%, taxanes to 37% vs 20% and platinum-based chemotherapy to 12% vs 2%, respectively. Among non-TNBC patients, 12% received Trastuzumab and 53% received hormonal treatment. Eighty four TNBC and 696 non-TNBC patients were asked regarding side effects as well as vitamins and supplements intake. Among them, 76 TNBC patients reported an average of 2.8 side effects (95% CI 1.0-8.0) vs 577 non-TNBC patients reporting an average of 2.8 side effects (95% CI 1.0-13.0); p < 0.92. Similarly, an average of 5.0 vitamins and supplements was reported by 64 TNBC patients (95% CI 10.0-17.0) and an average of 3.8 was reported by 555 non-TNBC patients (95% CI 1.0-29.0); p < 0.023. Toxicity and supplements are tabulated below. Conclusions: The real world evidence obtained through an international analysis shows that TNBC patients receive more toxic treatments due to the aggressive disease, as expected. However, TNBC patients experience similar toxicities with non-TNBC patients, but their consumption of vitamins and supplements is much higher. [Table: see text]

scholarly journals 281 Real-world-data on platinum outcomes after parp inhibitors progression in high grade serous ovarian cancer patients

2020 ◽  
Author(s):  
Andrea Plaja Salarich ◽  
Iris Teruel García ◽  
Beatriz Pardo Burdalo ◽  
Marta Gil-Martin ◽  
Josep Maria Piulats Rodriguez ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Real World ◽  
Parp Inhibitors ◽  
High Grade ◽  
Serous Ovarian Cancer ◽  
Real World Data ◽  
World Data

scholarly journals PARP Inhibitor in Platinum-Resistant Ovarian Cancer: Single-Center Real-World Experience

2021 ◽  
pp. 506-511
Author(s):  
Amit Agarwal ◽  
Saphalta Baghmar ◽  
Chandragouda Dodagoudar ◽  
Suhail Qureshi ◽  
Aseem Khurana ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Partial Response ◽  
Parp Inhibitor ◽  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Platinum Sensitive ◽  
Platinum Resistant ◽  
Proven Efficacy

PURPOSE Poly (ADP-ribose) polymerase inhibitors (PARPi) have proven efficacy in treatment of BReast CAncer ( BRCA) gene mutation-positive platinum-sensitive ovarian cancers. There is paucity of data for their role in platinum-resistant ovarian cancer (PROC). We report here retrospective analysis of outcome of PARPi treatment in a group of patients including those of PROC. PATIENTS AND METHODS We analyzed all consecutive patients who received PARPi. The efficacy of PARPi monotherapy was assessed in patients with relapsed high-grade serous ovarian carcinoma with g BRCAm. The drug was procured through compassionate program. Drugs (olaparib and talazoparib) were provided in capsule form. RESULTS Between July 1, 2015, and June 30, 2019, 28 patients with ovarian cancer received PARPi. At the time of data censoring (September 30, 2019), four (14.3%) patients are still on treatment. Median age was 54.5 years (range, 39-75 years). Median number of previous lines of chemotherapy received was three (range, 1-6). Eleven platinum-sensitive patients received the drug as maintenance (five in complete response and six in partial response after chemotherapy), whereas 17 (60.7%) had platinum-resistant progressive disease while starting the drug. In PROC, objective response rate (complete response plus partial response) was 47%, median progression-free survival was 8.2 months (5.3-11.3), and overall survival was 14.9 months (11.2-18.5). No new side effects were observed. CONCLUSION This is the first study from India evaluating PARPi in platinum-resistant ovarian cancer. This study suggests that PARPi is a viable treatment option in patients with PROC with gBRCAm. This should be further evaluated in randomized clinical trial.

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