Fig 1.
21 eligible patients were treated per protocol. A futility analysis was performed when 18 patients were evaluable for response (RECIST assessment after cycle 2 of therapy).
Table 1.
Patient characteristics (n = 21).
Table 2.
Adverse events.
Table 3.
Laboratory abnormalities.
Fig 2.
Hematologic toxicity and treatment exposure per cycle among 21 patients who received trial treatment.
Number of patients indicated on y-axis. Height of bars indicates the number of patients that are still receiving treatment at each timepoint. Hematologic toxicities are graded per CTCAE version 4.0 and are indicated by colored bars with darker colors indicating more severe toxicity in (A-C): (A) absolute neutrophil count; (B) platelet count; (C) hemoglobin). (D) Summary of treatment exposure per cycle with number of patients receiving full dose (dark blue) or undergoing dose reduction (light blue), dose delay (green) or treatment hold (grey).
Fig 3.
Efficacy of cisplatin, gemcitabine, pembrolizumab combination.
(A) Waterfall plot demonstrating best change from baseline in target lesion size. (B) Spider plot demonstrating best change in baseline in target lesion size over time. (C) Swimmer plot demonstrating response onset and duration. Response changes at each timepoint are indicated with symbols (CR with red triangle, PR with green square, SD with yellow inverted triangle, PD with purple circle). (D) Kaplan-Meier curve of progression-free survival. (E) Kaplan-Meier curve of overall survival.
Fig 4.
Response in four patients who had rising CA125 levels during trial treatment and received palliative radiation to a non-target lesion.
Y-axis: CA125. X-axis: cycle number. Block arrow indicates timing of radiation administered at a dose of 8 Gray x 3 cycles. (A) CA125 trend in three patients with high-grade serous ovarian cancer demonstrates continuing rise in CA125 levels after receiving radiation treatment. (B) Following palliative radiation, one patient with clear cell ovarian cancer demonstrated decline and normalization of CA125 levels as well as shrinkage of lesions outside of the radiation field and conversion or RECIST 1.1 response from SD to PR, suggesting potential induction of an abscopal response.
Table 4.
Clinical effect of gemcitabine + cisplatin combination with and without addition of pembrolizumab immunotherapy in platinum-resistant recurrent ovarian cancer.