Adverse Events Associated With Complementary and Alternative Use in Ovarian Cancer Patients

5580 Background: TTFields are a non-invasive, regional antimitotic treatment modality, which have been approved for the treatment of recurrent and newly diagnosed glioblastoma by the FDA. TTFields act by delivering intermediate frequency alternating electric fields to the tumor, predominantly by disrupting the formation of the mitotic spindle during metaphase. INNOVATE was the first trial testing TTFields (200kHz) in ovarian cancer patients. Methods: Thirty-one recurrent, platinum-resistant, unresectable ovarian cancer patients were enrolled in the INNOVATE trial and treated with TTFields in combination with weekly paclitaxel. The primary endpoint was treatment emergent adverse events. Secondary endpoints included progression free-survival, overall survival and radiological response rate. Results: The median age was 60 (range – 45-77), most patients (77%) had serous histology. 52% had an ECOG score of 0. The median number of prior chemotherapy regimens was 4.1 (range 1-11). All patients were platinum-resistant, and 97% of patients received prior taxane-containing regimens. Ten (32%) patients suffered from serious adverse events (SAEs) during the study, none were related to TTFields. Of all reported SAEs, 31% were related to gastrointestinal disorders (ileus, jaundice and ascites) and 31% were respiratory events (dyspnea, pleural effusion and pulmonary embolism). Only one SAE which, related to the tumor, led to permanent discontinuation of the device. Most patients were reported to have mild-moderate, TTFields-related skin irritation, out of whom only two patients (6.4%) had severe-grade events. The median PFS was 8.9 months (95% CI 4.7, NA). Of the evaluable tumors, 25% had partial response and another 46.4% stable disease – a clinical benefit of 71.4%. Six patients (19.4%) had a CA 125 response, translating into a decrease of 50% or more in serum levels. The median OS was not reached. Conclusions: TTFields concomitant to weekly paclitaxel are tolerable and safe in heavily pre-treated platinum-resistant ovarian cancer ovarian cancer patients. These data support further clinical testing of TTFields with chemotherapy in ovarian cancer. Clinical trial information: NCT02244502.

Download Full-text

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

Journal of Ovarian Research ◽

10.1186/s13048-021-00803-2 ◽

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.

Download Full-text

Comorbidities and Adverse Events in Advanced and Recurrent Ovarian Cancer Patients in France

Annals of Oncology ◽

10.1093/annonc/mdu338.38 ◽

2014 ◽

Vol 25 ◽

pp. iv317

Author(s):

O. Le Saux ◽

A. Taylor ◽

V. Chia ◽

D. Pillas ◽

G. Kafatos ◽

...

Keyword(s):

Ovarian Cancer ◽

Adverse Events ◽

Cancer Patients ◽

Recurrent Ovarian Cancer

Download Full-text

Effects of complementary and alternative medicine use on hopelessness in ovarian cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2008.26.15_suppl.9598 ◽

2008 ◽

Vol 26 (15_suppl) ◽

pp. 9598-9598

Author(s):

A. H. Gross ◽

J. Cromwell ◽

A. B. Kornblith ◽

H. Lee ◽

H. Li ◽

...

Keyword(s):

Ovarian Cancer ◽

Alternative Medicine ◽

Complementary And Alternative Medicine ◽

Cancer Patients ◽

Medicine Use ◽

Complementary And Alternative

Download Full-text

Potentially Dangerous Complementary and Alternative Medicine (CAM) Use by Ovarian Cancer Patients

Journal of Gynecologic Surgery ◽

10.1089/gyn.2011.0040 ◽

2012 ◽

Vol 28 (2) ◽

pp. 116-120 ◽

Cited By ~ 3

Author(s):

M. Robyn Andersen ◽

Erin Sweet ◽

Kimberly A. Lowe ◽

Leanna J. Standish ◽

Charles W. Drescher ◽

...

Keyword(s):

Ovarian Cancer ◽

Alternative Medicine ◽

Complementary And Alternative Medicine ◽

Cancer Patients ◽

Cam Use ◽

Complementary And Alternative

Download Full-text

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

10.21203/rs.3.rs-101839/v1 ◽

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.

Download Full-text

Adverse Events as a Potential Clinical Marker of Antitumor Efficacy in Ovarian Cancer Patients Treated With Poly ADP-Ribose Polymerase Inhibitor

Frontiers in Oncology ◽

10.3389/fonc.2021.724620 ◽

2021 ◽

Vol 11 ◽

Author(s):

Jing Ni ◽

Xianzhong Cheng ◽

Rui Zhou ◽

Qian Zhao ◽

Xia Xu ◽

...

Keyword(s):

Ovarian Cancer ◽

Adverse Events ◽

Cancer Patients ◽

Brca Mutation ◽

Parp Inhibitor ◽

Antitumor Efficacy ◽

Categorical Variables ◽

Rank Test ◽

Hematological Toxicity ◽

Clinical Marker

BackgroundPARP inhibitor (PARPi) is an important progress in ovarian cancer treatment. The available evidence suggests that BRCA mutation and homologous recombination deficiency (HRD) are effective biological markers for PARPi. Here we investigated the relationship between adverse events (AEs) and efficacy of PARPi in ovarian cancer patients.MethodsSeventy-eight patients with ovarian cancer patients underwent Olaparib and Niraparib from July 2018 to July 2020 were analyzed. AEs were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Chi-square test or fisher exact tests was performed to observe the association between categorical variables. Logistic regression analysis was conducted to investigate the independent variables for disease control response (DCR). Progression-free survival (PFS) was compared between AEs variables by log-rank test.ResultsPatients with AEs in the first one week had a higher DCR compared with those after one week (86.11% versus 60.98%, p=0.013). Patients with serious AEs (SAEs) had a significantly higher DCR (81.40% versus 60.60%, p=0.045). There were associations between anemia and DCR in both occurrence (79.63% versus 56.52%, p=0.037) and grade (100% versus 73.17%, p=0.048). The median PFS of patients with hematological toxicity was longer than that of patients with no-hematological toxicity (30 versus 20 weeks, p=0.047). Patients with hematological toxicity within four weeks had prolonged median PFS than those with hematological toxicity after four weeks (40 versus 22 weeks, p=0.003).ConclusionsThe early presence of AEs and SAEs in hematological toxicity of PARPi were related to the antitumor efficacy, which might be a valid and easily measurable clinical marker in ovarian cancer patients.

Download Full-text