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Evaluation of symptom burden in patients receiving concurrent biochemotherapy for metastatic malignant melanoma (MMM).

6143 Background: Combination of cytotoxic chemotherapy and immunoregulators (biochemotherapy) is commonly used to treat patients with MMM. Response rates reported with this regimen vary between 18% and 60%. This treatment course is limited by acute toxicity and the resulting substantial symptom burden.


METHODS
Using the M. D. Anderson Symptom Inventory (MDASI) and ECOG performance status (PS), we evaluated the symptom burden in 12 patients receiving 1-5 cycles of concurrent biochemotherapy for MMM. Patients received Dacarbazine 800mg/m2 D1, Cisplatin 20 mg/m2 D1-4, Vinblastine 1.5 mg/m2 D1-4, Interleukin-2 9 MU/m2 IVCI D1-4, and Interferon-alpha-2b 5 MU/m2 SC D1-4. The MDASI was administered at baseline and daily for 21days. ECOG PS was evaluated at baseline and day 5. Data was collected by personal interview during hospitalization and by daily mail after discharge.


RESULTS
Most significant symptoms included fatigue, nausea, sleep disturbance, depressed appetite, drowsiness, dry mouth, and itching. Symptom intensity was graphed over time to develop a symptom curve. Consistently, the symptoms peaked at day 4 to 5 and returned almost to baseline levels at day 21. ECOG PS decreased from day 0 to day 5 and returned to baseline prior to the next treatment cycle. The table below shows the 7 highest reported symptoms rated on a 0-10 scale.


CONCLUSIONS
Concurrent biochemotherapy induces substantial toxicity during the first 5-7 days of therapy. Acute toxicity seems tightly related to drug administration. Short-term symptom burden is more severe than seen with most treatment modalities. If substantial tumor response is not evident after 2 courses of therapy, the treatment-related symptom burden further limits its overall clinical benefit. Future studies will assess correlations with serum release of various cytokines and compare with high-dose Interleukin-2. [Figure: see text] No significant financial relationships to disclose.