Wlk

Figure 9-6. KaplanMeier curves of survival for patients treated with pegylated liposomal doxorubicin or topotecan. Survival was significantly prolonged for patients treated with pegylated liposomal doxorubicin compared with those treated with topotecan. Neither of these single agents has been compared in any study with a platinum drug (see Fig. 9-2). (From Gordon AN, Tonda M, Sun S, et al: Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol 95:1-8, 2004, Figs. 1-4.)

37 weeks).12,26 One possible explanation for this somewhat surprising finding is that much of the difference in overall survival resulted from what happened to patients after they completed treatment on this protocol.

It is reasonable to speculate that for the women entered into this trial oncologists would subsequently have desired to administer carboplatin after progression, because this was a potentially platinum-sensitive patient population (although the individuals entered into this trial initially received the study medications before re-treatment with the platinum). It is possible (although no specific data are available to prove this hypothesis) that patients who received the relatively nonmyelosuppressive lipo-somal doxorubicin were able to be treated with a reasonable course of carboplatin following progression, whereas it was more difficult to deliver carboplatin after treatment with topotecan, a recognized more myelotoxic antineoplastic agent.12,26

100 120 140 160 180 200 220 240 260

Weeks since first dose

Pegylated liposomal doxorubicin (n = 109) Topotecan (n = 110)

100 120 140 160 180 200 220 240 260

100 120 140 160 180 200 220 240 260

Weeks since first dose

Pegylated liposomal doxorubicin (n = 130)

Note that it has been theorized that by treating recurrent ovarian cancer patients with a non-platinum agent before a platinum drug in the recurrent disease setting (so-called "artificially extending the platinum-free interval"), it may be possible to increase the percentage of individuals who respond to the platinum drug when it is subsequently administered. Although this is a provocative concept, unfortunately no prospectively obtained randomized clinical data are available to support this proposal. Moreover, it is at least equally possible that by delaying the administration of platinum until the third-line setting, the effectiveness of the platinum agent may be reduced.27 Furthermore, as previously noted, the toxicity produced by the second-line nonplatinum strategy may even make it more difficult to deliver an optimal subsequent course of a platinum drug.12,26

It is also relevant to note that currently no evidence exists for the superiority of any combination non-platinum-containing regimen in recurrent ovarian cancer compared with the administration of a single agent. Therefore, with the exception of individuals participating in clinical trials, single-agent therapy is the preferred choice in this clinical setting.

Finally, the potential role of surgery in recurrent ovarian cancer must be considered in the context of the decision to deliver chemotherapy in this patient population. Although there are no evidence-based trials that have documented the usefulness of this therapeutic approach or that critically define the specific patient subgroups for whom such surgery should be carried out, considerable retrospective data suggest that patients with relatively long treatment-free intervals and potentially surgically resectable disease may benefit from this strategy prior to the delivery of second-line cytotoxic chemotherapy.28 The results of ongoing phase III trials directly addressing the issue of defining a role for secondary cytoreductive surgery in the management of ovarian cancer are awaited with considerable interest.

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