9 12

Time since randomization (weeks)

Paclitaxel plus platinum Conventional treatment

Figure 9-4. Reactions to platinum-based chemotherapy. A, Global health status. B, Fatigue. C, Nausea and vomiting. D, Pain over time. The same patients do not contribute to each point. (From The ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet 361:2099-2106, 2003, Fig. 6.)

Although several hypotheses may be proposed to explain the lack of overall survival benefits observed in this trial, perhaps the most likely is the fact that a larger percentage of patients in the carboplatin versus carboplatin plus gemcitabine trial received further chemotherapy after progression compared with the number of individuals receiving additional treatment when therapy on ICON-4 was completed. Though only a theory, it has recently been documented that active chemotherapy in the third-line setting can exert a statistically significant impact on survival independent of prior therapy the patient may have received22 (Table 9-4).

As might have been anticipated, no difference was seen in the risk of serious neuropathy between the two treatment regimens (carboplatin plus gemcitabine versus carboplatin), since gemcitabine is itself not considered neurotoxic.11

A randomized phase III trial that compared the combination of carboplatin plus liposomal doxorubicin with carboplatin plus paclitaxel is currently nearing completion, with the results hoped to be available in the near future.23 It is possible that the outcome of this study will permit the addition of another combination regimen

Table 9-4. Evidence for the Impact of Third-Line Therapy on Survival in Ovarian Cancer

Randomized Phase III Canfosfamide (TLK 286) Liposomal Doxorubicin or

Trial Comparison (Experimental Arm) Topotecan (Control Arm)

Objective response rate 4.3% 10.9%

Progression-free survival 2.3 months 4.4 months (P = .0001) (median)

Overall survival (median) 8.5 months 13.6 months (P = .0001)

Data from Vergote I, Finkler N, del Campo J, et al: Single agent, canfosfamide versus pegyiated doxorubicin or topotecan in 3rd line treatment of platinum refractory or resistant ovarian cancer: phase 3 study results. J Clin Oncol 25 (18S) (part II):966s-(Abstract #LBA55289), 2007.

to the list of programs whose usefulness in recurrent ovarian cancer has been documented in evidence-based clinical trials.

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