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Survival and Long-Term Toxicity Results in the SCOTROC Study: Docetaxel-Carboplatin (DC) vs. Paclitaxel-Carboplatin (PC) in Epithelial Ovarian Cancer (EOC)

Reviewer: Thomas Dilling, MD
The Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 20 de mayo del 2002

Presenter: P.A. Vasey
Presenter's Affiliation: Scottish Gynaecological Cancer Trials Group
Type of Session: Scientific

Background

• The Scottish Gynaecological Cancer Trials Group undertook a study of DC vs. PC in FIGO stage 1C-4 EOC.
• Data presented at ASCO last year demonstrated equivalent response rates in both arms.
• However, it was noted the DC patients had diminished neuropathy symptoms, though increased myelosuppression compared with patients on the PC arm.

Materials and Methods

• 1077 patients were enrolled from October, 1998 to May, 2000.
• Patients were randomized to DC or PC x 6 cycles.
• Median follow-up is now 23 months.
• Quality of Life (QOL) data was also obtained from patients during treatment and thereafter.
• Neurotoxicity data was also accumulated via patient questionnaire and serial neurologic exams.
• QOL tools included the EORTC QLQ-C30 (v. 3.0), which assesses global QOL.
• In addition, the researchers developed EORTC QLQ-OV28 (v. 1.0), a more specific module assessing domains more relevant to ovarian cancer patients. The presenter did not provide further information regarding development of this module or independent validation of its efficacy.

Results

• To date, the PFS and OS curves overlap. The presenter states that an additional year of follow-up will be necessary to determine this with certainty.
• Median PFS is 15.4 months (PC) vs. 15.1 months (DC).
• 2-year OS is 69.8% (PC) vs. 65.4 months (DC).
• No significant interactions were found with patient age, extent of residual disease, or patient age.
• Global QOL scores, as ascertained by the QLQ-C30 were statistically comparable in both arms.
• More specific data from the QLQ-OV28, however, was highly significant, with all items assayed favoring DC.
• Specifically, the author mentioned the following as statistically significant in QOL analysis, all favoring the DC arm: neurotoxicity ("pins/needles and numbness"), myalgias ("aches and pains"), alopecia, weakness of the arms or legs, body image, pain scores, insomnia, gastrointestinal symptoms.

Author's Conclusions

• The survival data in both arms appear to be equivalent (though data analysis is ongoing).
• QOL data, however, appeared to strongly favor the DC arm.

Clinical/Scientific Implications

• As oncologists have shifted chemotherapeutic treatment from single-agent therapy to combinations of drugs, data on a number of various combinations have been accrued.
• Unfortunately, no single combination has proven greatly better than the others in the treatment of EOC.
• Given this fact, oncologists need to determine chemotherapeutic regimens that have equivalent survival data but diminished toxicity for the patient.
• Data on this study are still accruing, but thus far appear to favor DC over PC, by demonstrating equivalent tumor response, but with less disruption of patients' QOL perceptions.

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.