Abstract

Switch maintenance, or using alternative therapeutic agents that were not administered during a prior course of cancer treatment, has emerged as an active clinical research and regulatory agency-approvable path in the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) drug-development sequence. To better inform the design of therapeutic radiopharmaceutical trials, we reviewed academic scholarship discussing the clinical use of maintenance approaches to cancer treatment. Women with advanced-stage primary platinum-refractory or platinum-resistant ovarian carcinoma and their courses of treatment provide context for our discussion. Twenty-four (10%) out of 244 trials for women with ovarian carcinoma fit our search terms for maintenance trials. Five (2%) trials studied radiopharmaceuticals as switch maintenance. In our opinion, radiopharmaceutical switch maintenance merits further testing in prospective trials for women with advanced-stage primary platinum recurrent or refractory ovarian carcinoma.

Highlights

  • In 2020, one percent (21,750 women) of all new cancer cases in the United States are women newly diagnosed with ovarian carcinomas [1]

  • A switch maintenance approach for primary platinum-refractory ovarian carcinoma has gained interest and recent regulatory approval [5,6]. Such an approach largely fits into one of two therapeutic strategies—(i) a switch maintenance strategy, whereby after conventional first-line therapy patients are switched to an alternative agent or combination of agents until disease progression, or (ii) a continuation maintenance strategy, whereby one treatment of the first-line is continued past its standard duration alone or in a new combination until disease progression [7]

  • Radioimmunotherapy trials establish a foundation upon which generation therapeutic radiopharmaceutical maintenance trials can be designed

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Summary

Introduction

In 2020, one percent (21,750 women) of all new cancer cases in the United States are women newly diagnosed with ovarian carcinomas [1]. There is an unmet therapeutic need for safe and effective treatment for an estimated 5438 (25% [4]) newly diagnosed American women each year whose ovarian carcinoma falls into the primary platinum-refractory disease category. A switch maintenance approach for primary platinum-refractory ovarian carcinoma has gained interest and recent regulatory approval [5,6] Such an approach largely fits into one of two therapeutic strategies—(i) a switch maintenance strategy, whereby after conventional first-line therapy patients are switched to an alternative agent or combination of agents until disease progression, or (ii) a continuation maintenance strategy, whereby one treatment of the first-line is continued past its standard duration alone or in a new combination until disease progression [7]. A maintenance strategy might more broadly squeeze between prior-line and next-line treatment, such that radiopharmaceuticals are not necessarily boxed-in by first-line and second-line therapies (Figure 1)

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