Prospective assessment of quality of life in ovarian cancer patients receiving whole abdomen hyperthermia and liposomal doxorubicin.

PURPOSE: Prospective assessment of quality of life (QoL) in patients with refractory, residual or recurrent ovarian cancer receiving whole abdomen hyperthermia and intravenous liposomal doxorubicin chemotherapy. METHODS: Treatment consisted of six cycles of intravenous liposomal doxorubicin at 40 mg m2 followed by whole abdomen hyperthermia with each cycle delivered every 4 weeks. QoL assessment was performed at baseline, prior to each cycle of chemotherapy and every 3 months during follow-up using self-administered questionnaires. Global QoL was rated on a seven-point scale and specific domains of QoL, disease related symptoms and treatment related toxicity were rated on a four-point scale. RESULTS: Thirty-two patients were enrolled on the study and 129 QoL questionnaires were completed. Average age was 57.9 (range 45-76); nine patients had persistent and 23 recurrent disease. Ten patients completed six cycles of therapy. Three patients returned follow-up surveys. Subjects rated their overall QoL and health at baseline as above average with mean scores 5.10 (95% CI=4.62-5.58) and 4.66 (95% CI=4.23-5.08), respectively. No significant change in overall QoL was found between baseline and cycles 4-6 of therapy. Mean ratings of overall health and subject reported differences in QoL between cycles were not significantly changed during therapy. Limited follow-up data were available, but scores suggest possible improvement in QoL for patients completing all therapy. Subjects rated the greatest negative impact on QoL in areas of role functioning and social functioning, where the mean (SD) over all cycles was 2.00 (0.67) and 1.98 (0.70), respectively. For physical symptoms, fatigue and sleep disturbance had the most negative impact on QoL with means (SD) of 2.26 (0.62) and 1.91 (0.70). The moderate treatment related toxicity seen in this study did not significantly impact patients reported QoL. CONCLUSIONS: Patients with unfavourable ovarian cancer responding to intravenous liposomal doxorubicin and whole abdomen hyperthermia maintained above average QoL during therapy. Limited data on patients completing protocol therapy demonstrated possible improvement in QoL.

Anaphylactoid reactions with intraperitoneal cisplatin.

OBJECTIVE: To report the occurrence of anaphylactoid reactions to intraperitoneal cisplatin in 3 patients. CASE SUMMARIES: While conducting a protocol evaluating the efficacy of intraperitoneal cisplatin and hyperthermia in the treatment of recurrent ovarian cancer, 3 patients were noted to exhibit anaphylactoid reactions. A 43-year-old woman received cisplatin 60 mg/m2 in 15 minutes during her sixth cycle of therapy. She developed pruritus, edema, and urticaria over both hands. The reaction subsided after treatment with diphenhydramine and dexamethasone. A 57-year-old woman received 400 mL (62.4 mg) of a cisplatin solution concentrated to deliver cisplatin 100 mg/m2 during her first attempted therapy. At this point, she developed whole body urticaria and pruritus with edema of the extremities. The reaction was aborted with diphenhydramine and dexamethasone. Despite premedication with dexamethasone prior to a second attempt at therapy, she again experienced similar symptoms after receiving 500 mL (78 mg) of cisplatin solution. A 55-year-old woman received 2 cycles of therapy with cisplatin 100 mg/m2 without difficulty. During her third cycle, she again received cisplatin 100 mg/m2 over 30 minutes and developed palmar pruritus, urticaria, and edema. Symptomatology resolved with diphenhydramine. Despite premedication with diphenhydramine and dexamethasone, she experienced generalized pruritus and urticaria, as well as headache and chest pain/tightness, after her next infusion. For both the second and third patients, symptomatology failed to resolve until the intraperitoneal cisplatin solution was withdrawn. DISCUSSION: Anaphylactoid reactions have been described previously with cisplatin administration. No dose-rate effect has been reported, however. We observed 5 reactions in 3 patients that appear to be related to a high dose-infusion time ratio, indicating that dose and rate of infusion may be important factors in precipitating anaphylactoid reactions with cisplatin. CONCLUSIONS: We conclude that a high dose combined with a short infusion time increases the risk of anaphylactoid reactions with the administration of intraperitoneal cisplatin. There was no indication that the increase in anaphylactoid reactions was associated with the use of hyperthermia.

Cumulative minutes with T90 greater than Tempindex is predictive of response of superficial malignancies to hyperthermia and radiation.

PURPOSE: To better define thermal parameters related to tumor response in superficial malignancies treated with combined hyperthermia and radiation therapy. METHODS AND MATERIALS: Patients were randomized to receive one or two hyperthermia treatments per week with hyperthermia given during each week of irradiation. Hyperthermia was given for 60 min with treatments begun within 1 hr following irradiation. Power was increased to patient tolerance or normal tissue temperature of 43.0 degrees C. Irradiation was generally given 5 times per week with doses prescribed to normal tissue tolerance (generally 24-70 Gy at 1.8-2.5 Gy per fraction). Multipoint thermometry was used with temperatures obtained every 5 min. RESULTS: One hundred eleven individual treatment fields containing 1 or more tumor nodules were completely evaluable. The complete and overall response rates were 46% and 80%, respectively. Forty-one percent of all treatment fields (51% of responding lesions) remained controlled at 2 years. Multivariate analysis revealed that the cumulative minutes that the temperature achieved by 90% of the measured tumor sites (T90) was > or = 40.0 degrees C, tumor histology, tumor volume, and radiation dose were significantly associated with complete tumor response. The complete response rate was not significantly affected by the number of hyperthermia treatments given per week. The incidence of clinically significant complications was low. CONCLUSIONS: These results support the usefulness of the cumulative minute system in describing time-temperature relationships. The significance of thermal variables with regard to tumor response strongly supports the contention that hyperthermia can be a useful adjunct to irradiation for the local control of cancer.