Background: Chemotherapy with paclitaxel and carboplatin 3-weekly is active in many tumors. Major toxicities are myelosuppression and neurotoxicity. Weekly administration of taxanes allows high dose intensity with reduced toxicity. Patients and Methods: 131 patients with solid tumors were treated as outpatients with paclitaxel 75 mg/m² and carboplatin AUC 2–3 days 1, 8, 15 every 4 weeks irrespective of pretreatment and partly in neoadjuvant and multimodal concepts. Results: 125 patients (median age 58 years) were evaluable for response and toxicity, of whom 45 suffered esophageal carcinoma (19 patients in neoadjuvant treatment) and 31 non-small cell lung cancer. 49 patients were pretreated. 23 patients received concomitant radiotherapy of esophagus or lung in doses ranging from 40 to 60 Gy. We observed a low hematologic toxicity with 15.2% grade-III/IV leukopenia/granulocytopenia and 3.2% thrombocytopenia grade III/IV. Neurotoxicity grade II was reported in 14 patients. Main toxicity with radiotherapy was esophagitis grade II or III in 7 out of 23 patients. Overall response rate was 54.2%. 5 out of 19 patients treated neoadjuvantly for esophageal cancer reached a pathological complete response. Conclusions: Weekly paclitaxel and carboplatin is safe and feasible in outpatients and a high dose intensity can be achieved. The favorable toxicity profile allows treatment of elderly and pretreated patients. Response rate is high including pathological complete responses and responses appear quickly, making this therapy most suitable for multimodal and neoadjuvant treatments.

Objectives: The purpose of this investigation was firstly to assess the overall frequency of subjectively experienced symptoms self-reported by patients receiving endocrine therapy and secondly to compare these symptoms with side effects assessed by clinicians in pivotal trials. Methods: Unselected patients with early and advanced breast cancer receiving endocrine therapy were approached consecutively during a routine outpatient visit. They received a questionnaire called Checklist for Patients with Endocrine Therapy (C-PET), a validated self-assessment tool to determine prespecified symptoms associated with endocrine therapy. Data on toxicity were also obtained from previously published trials. Results: 405 patients were approached and 373 agreed to participate in this study. Some symptoms were significantly more often recorded by the women in the adjuvant setting completing the C-PET than by physicians’ reports in pivotal trials: hot flushes/sweats (C-PET 70%, ATAC 40% and BIG1-98 38%), low energy (C-PET 45%, ATAC 15% and BIG1-98 9%), fluid retention (C-PET 22% and BIG1-98 7%) and vaginal dryness (C-PET 30% and BIG1-98 3%). Similar differences were observed in the metastatic and adjuvant setting. Conclusions: A simple tool like the C-PET questionnaire is able to reflect the treatment burden of endocrine therapies and may be helpful to improve communication between patients and care providers. Some symptoms were significantly more often reported by the women in the C-PET than by physicians in pivotal trials.

No abstract

9104 Background: Taste alterations (TA) can occur as side-effects of taxane-based chemotherapy (T-Ch) and studies suggest that glutamin can reduce neurotoxicity. We compared in patients (pts) with a first time T-Ch oral glutamin (G) with placebo (P) for occurrence and severity of TA. Methods: Pts were randomised for 30g per day G or P (maltodextrin) (Baxter, Switzerland) from the first day of T-Ch. Subjective TA (dysgeusia) was measured daily by VAS, at baseline 3 times. On each cycle of T-Ch, objective (sour, sweet, salty, bitter) and subjective (4-categorical scale of 4 tastes) TA, and toxicity (NCI CTC V.3) were assessed. Stomatitis and zinc deficiency were screened for and treated. Of 47 pts receiving at least one day G or P, three (2 G, 1 P) died to tumor progression and three (2 G, 1 P) withdraw consent in the first cycle of T-Ch. For primary outcomes, repeated dysgeusia scores were analyzed by linear mixed model and repeated binary values of each objective taste item by generalized estimating equation using logit link function. Results: G (n=21) and P (n=20) pts groups were comparable for demographics (f:m 5:16, median age 67 [49,83], 9 prostate, 3 lung, 3 breast, 6 other cancer; 8:12, 63 [40,73], 2, 6, 6, 6), and T-Ch drug (docetaxel 11/paclitaxel 10; 7/13), schedule (weekly 18/3-weekly 3; 14/6), or goal (adjuvant 1/palliative 20; 5/15). At baseline, average median dysgeusia was 11 in both groups (0,90; SD 23. 0,99; 22), 4 tastes were recognized by 12, 16, 13, and 15 pts in G (n=16) and 16, 19, 17, 19 in P (n=20). Study duration was 73 days for G (median; 4, 385) and 74 for P (7, 187). 19 of 39 pts (11 G, 8 P) developed peripheral neuropathy G1 or G2, none G3. Maximal (mean) dysgeusia was 31 (1, 100) in G and 33 (4, 74) in P; increase from baseline was 20 (1, 100) and 22 (1, 63). No effect of G or P on dysgeusia was detected (p=ns), linear time effect was p=0.46. Baseline dysgeusia effect was significant (p<0.0001), two group analysis (dysgeusia =11) did not alter results. Objective taste tests (no baseline effect) or subjective TA were not different, as were adverse events. Conclusions: Oral glutamin at the dose given did not decrease subjective taste disturbances or altered taste perception associated with T-Ch compared to placebo. No significant financial relationships to disclose.