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• W1903987727 abstract "5579 Background: Paclitaxel and cis- or carboplatin have shown efficacy in metastatic or recurrent head & neck cancer when administered in two- to four-weekly cycles. We assumed that a dose-dense weekly therapy with reduced single doses could show tolerability advantages while maintaining efficacy. Methods: We recruited patients with histologically proven metastatic, residual, or recurrent squamous cell carcinoma of the head or neck, who had no options for surgery or radiotherapy (RT). Patients with contraindications to chemotherapy, an ECOG status >2 and a life-expectancy <12 weeks were excluded. Patients received on an outpatient basis six weekly courses of paclitaxel 90 mg/m2 as a 60 min infusion after usual premedication, followed by carboplatin dosed to AUC=2 as a 30 min infusion (six courses=one cycle). Patients showing progression (PD) went off study. Complete or partial responders (CR, PR) or those showing no or minimal change (SD) received a second therapy cycle. Tumour status was assessed after each cycle. Doses were reduced (paclitaxel 80 mg/m2; carboplatin AUC=1) on signs of haematotoxicity or Grade 3 mucositis Results: : We recruited 52 patients (43 male, 9 female; median age=58.5 years; median ECOG status=1). All patients had previously received RT, 42 had surgery. Tumour stage was T3 or T4 in 30/52 patients, N2 in 25/52, M0 in 42/52; tumour grade was G2 in 22/52 and G3 in 24/52. Patients received 1 to 18 therapy courses (median: 11). In 45 patients response could be assessed. Both confirmed and unconfirmed response rates were 60% (confirmed: CR 2%; PR 20%; SD 38%). Median time to progression in confirmed CR+PR was 309 days, median time to progression in all patients 113 days. Median survival time was 195 days. Grade 3 or 4 toxicities were rare: Anorexia 6 of 47 evaluable patients, dysphagia 1/50, headache 1/51, motoricity 2/50, nausea 1/51, haemoglobin 1/52, ALAT 1/50 Conclusions: Our dosing schedule of paclitaxel and carboplatin was well tolerated and efficacious. Its response rate and survival time are comparable to cisplatin-based inpatient therapies, its tolerability profile makes it suitable for outpatient therapy. No significant financial relationships to disclose." @default.
• W1903987727 created "2016-06-24" @default.
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• W1903987727 date "2004-07-15" @default.
• W1903987727 modified "2023-09-25" @default.
• W1903987727 title "Paclitaxel and carboplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. A phase II study" @default.
• W1903987727 doi "https://doi.org/10.1200/jco.2004.22.90140.5579" @default.
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