Real-world treatment drop-off among recurrent or metastatic cervical cancer patients: A US community oncology-based analysis

Alholm, Zachary; He, Dalin; Tan, Jie; Zhang, Yitong J.; Sudharshan, Lavanya; Leong, Traci; Coleman, Robert L.; Monk, Bradley J.

doi:10.1016/j.ygyno.2022.07.026

Cited by 8 publications

(5 citation statements)

References 28 publications

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“…Our finding that nearly half of 1L-treated patients with r/mCC received 2L therapy is consistent with a recent study that followed patients with r/mCC from 2014 to 2020 in the US Oncology Network, reporting that 48 % of 1L-treated patients received 2L therapy ( Alholm et al, 2022 ). To our knowledge, these are the only two studies so far that estimated real-world receipt of 2L therapy and its predictors among contemporary patients with r/mCC.…”

Section: Discussionsupporting

confidence: 92%

Factors associated with receipt of second-line recurrent or metastatic cervical cancer treatment in the United States: A retrospective administrative claims analysis

Sonawane

Castellano

Washington

et al. 2022

Gynecologic Oncology Reports

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Section: Discussionsupporting

confidence: 92%

Factors associated with receipt of second-line recurrent or metastatic cervical cancer treatment in the United States: A retrospective administrative claims analysis

Sonawane

Castellano

Washington

et al. 2022

Gynecologic Oncology Reports

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“…Doublet combination regimens of TV with bevacizumab, carboplatin, or pembrolizumab demonstrated acceptable safety and encouraging antitumor activity in patients with advanced r/mCC in the dose-escalation phase. Treatment history was similar to the real-world population, 10,18,19 with the majority of patients having previous 1L bevacizumab 1 platinum doublet chemotherapy or previous chemoradiotherapy. Across arms A, B, and C, most AEs were grade 1/2 and no DLTs occurred with the TV-doublet combinations.…”

Section: Discussionmentioning

confidence: 92%

Tisotumab Vedotin in Combination With Carboplatin, Pembrolizumab, or Bevacizumab in Recurrent or Metastatic Cervical Cancer: Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study

Vergote,

Van Nieuwenhuysen,

O'Cearbhaill

et al. 2023

JCO

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PURPOSE Tissue factor is highly expressed in cervical carcinoma and can be targeted by tisotumab vedotin (TV), an antibody-drug conjugate. This phase Ib/II study evaluated TV in combination with bevacizumab, pembrolizumab, or carboplatin for recurrent or metastatic cervical cancer (r/mCC). METHODS This open-label, multicenter study (ClinicalTrials.gov identifier: NCT03786081 ) included dose-escalation arms that assessed dose-limiting toxicities (DLTs) and identified the recommended phase II dose (RP2D) of TV in combination with bevacizumab (arm A), pembrolizumab (arm B), or carboplatin (arm C). The dose-expansion arms evaluated TV antitumor activity and safety at RP2D in combination with carboplatin as first-line (1L) treatment (arm D) or with pembrolizumab as 1L (arm E) or second-/third-line (2L/3L) treatment (arm F). The primary end point of dose expansion was objective response rate (ORR). RESULTS A total of 142 patients were enrolled. In dose escalation (n = 41), no DLTs were observed; the RP2D was TV 2 mg/kg plus bevacizumab 15 mg/kg on day 1 once every 3 weeks, pembrolizumab 200 mg on day 1 once every 3 weeks, or carboplatin AUC 5 on day 1 once every 3 weeks. In dose expansion (n = 101), the ORR was 54.5% (n/N, 18/33; 95% CI, 36.4 to 71.9) with 1L TV + carboplatin (arm D), 40.6% (n/N, 13/32; 95% CI, 23.7 to 59.4) with 1L TV + pembrolizumab (arm E), and 35.3% (12/34; 19.7 to 53.5) with 2L/3L TV + pembrolizumab (arm F). The median duration of response was 8.6 months, not reached, and 14.1 months, in arms D, E, and F, respectively. Grade ≥3 adverse events (≥15%) were anemia, diarrhea, nausea, and thrombocytopenia in arm D and anemia in arm F (none ≥15%, arm E). CONCLUSION TV in combination with bevacizumab, carboplatin, or pembrolizumab demonstrated manageable safety and encouraging antitumor activity in treatment-naive and previously treated r/mCC.

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“…CC patients were identified as patients aged 18 years and above with ≥1 inpatient claim or ≥2 outpatient claims with a diagnosis for malignant neoplasm of the cervix (identified by the International Classification of Diseases Codes 180.XX and C53.XX, where ‘X’ represents wildcard characters). We used a previously validated algorithm to identify r/mCC patients based on commencement of systemic treatment 18,19 . Briefly, patients with r/mCC were identified as CC patients who had ≥1 claim for systemic therapies included in guidelines for treatment of r/mCC on or after the first CC diagnosis date.…”

Section: Methodsmentioning

confidence: 99%

“…We used a previously validated algorithm to identify r/mCC patients based on commencement of systemic treatment. 18,19 Briefly, patients with r/mCC were identified as CC patients who had ≥1 claim for systemic therapies included in guidelines for treatment of r/mCC on or after the first CC diagnosis date. Therapies that included concomitant radiation therapy or surgery within 45 days were excluded as a line of therapy in the r/mCC setting.…”

Section: Patient Populationmentioning

confidence: 99%

Assessing Geographic Variation in Rates of Cervical Cancer and Recurrent or Metastatic Cervical Cancer Among Medicaid Enrollees

Leath

Nysenbaum

Tan

et al. 2023

American Journal of Clinical Oncology

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Objective: The objective of this study was to evaluate trends in prevalence of cervical cancer (CC) and rates of recurrent or metastatic cervical cancer (r/mCC) treatment initiation at the state and metropolitan statistical area (MSA) levels among Medicaid enrolled females from 2016 to 2019. Methods: Retrospective analyses of nationwide Medicaid claims data were used to identify adult CC and r/mCC patients from 2016 to 2019. CC prevalence was estimated as the proportion of females diagnosed with CC out of all adult female Medicaid beneficiaries, and r/mCC by the proportion of CC patients who initiated a systemic treatment not associated with surgery or radiation to the number of enrollees with CC diagnosis in each state or MSA. Overall and annual rates were calculated for each state and MSA from 2016 to 2019. Results: The analytic cohort included 70,865 adult female Medicaid beneficiaries with CC from 2016 to 2019, among whom 3375 were identified as r/mCC patients. Nationwide annual prevalence of CC remained relatively stable from 2016 to 2019, while r/mCC decreased slightly over the study period. Several MSAs experienced increasing rates of r/mCC from 2016 to 2019, including Mayaguez, PR, Aguadeilla-Isabela, PR, and Green Bay, WI. Conclusions: Claims data demonstrate areas in the United States with disproportionately high or increasing CC or r/mCC burden, indicating a potential gap in preventative care for females and an unmet need for education and health care resource allocation. Future research should evaluate associations between community-level factors and r/mCC burden.

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Real-world treatment drop-off among recurrent or metastatic cervical cancer patients: A US community oncology-based analysis

Cited by 8 publications

References 28 publications

Factors associated with receipt of second-line recurrent or metastatic cervical cancer treatment in the United States: A retrospective administrative claims analysis

Factors associated with receipt of second-line recurrent or metastatic cervical cancer treatment in the United States: A retrospective administrative claims analysis

Tisotumab Vedotin in Combination With Carboplatin, Pembrolizumab, or Bevacizumab in Recurrent or Metastatic Cervical Cancer: Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study

Assessing Geographic Variation in Rates of Cervical Cancer and Recurrent or Metastatic Cervical Cancer Among Medicaid Enrollees

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