Phase II trial of cisplatin and capecitabine in patients with squamous cell carcinoma of the head and neck, and correlative study of angiogenic factors

Abstract

The combination of cisplatin and capecitabine was evaluated in patients with recurrent or unresectable squamous cell carcinoma of the head and neck (HNSCC), and outcome parameters were correlated with the expression of thymidine phosphorylase (TP), thymidilate syntetase (TS), vascular endothelial growth factor receptor (VEGFR) 1 -3, and microvessel density (MVD). Patients with recurrent or unresectable HNSCC were eligible if they had received prior neoadjuvant chemotherapy, concurrent chemoradiotherapy, or no prior systemic therapy. Patients received cisplatin (75 mg m À2 day 1), and capecitabine (2000 mg m À2 day 1 -14) every 3 weeks. A total of 41 patients received 194 cycles. In all, 16 complete responses (39%) and 12 partial responses (29%) were documented, for an overall response rate of 68% (95% CI, 53 -80%). Grade 3 -4 uncomplicated neutropenia was documented in five subjects. Asthenia, anorexia, hand -foot syndrome, and constipation were the most frequent nonhaematologic events. Median progression-free and overall survival were 6.4 and 12.6 months. Cytoplasmic TP expression was more prevalent in patients with a laryngeal location vs other, and in patients with a recurrence vs primary disease. Microvessel density count was higher in patients with recurrent vs primary disease. The combination of cisplatin and capecitabine is effective in recurrent or unresectable HNSCC, and shows a manageable toxicity.

A phase II study of capecitabine plus cisplatin in metastatic triple-negative breast cancer patients pretreated with anthracyclines and taxanes

“…[14][15][16][17] Besides, relatively longer duration of response associated with capecitabine compared with other cytotoxic agents might be an advantage when added to cisplatin, which could contribute to a possible survival benefit of XP combination compared with other cisplatin-containing regimens. In fact, XP regimen was found to be effective and well tolerated in multiple advanced solid tumors in phase II trials, including gastric cancer, 29,30 squamous cell carcinoma of head and neck, 31,32 and biliary tract cancer. 33 These results further lent some confidence to its application in breast cancer patients.…”

Phase II study of capecitabine as palliative treatment for patients with recurrent and metastatic squamous head and neck cancer after previous platinum-based treatment

“…The results observed (CR of 78.4%, PR of 16.2% and 2-year OS of 57.9%) were comparable with those reported in most chemoradiotherapy studies. Hitt et al (2004) evaluated the capecitabine/cisplatin combination in 41 patients with recurrent and/or metastatic squamous HNC, observing an ORR of 68% (RC 39%, RP 29%). Only five patients (12%) had received PBT.…”

Update on role of chemotherapy in head and neck squamous cell cancer

“…Phase-III trials comparing combination regimens to single-agent chemotherapy in metastatic/recurrent HNSCC revealed higher response rates and increased toxicity with [59][60][61][62][63][64][65][66][67][68][69][70] In a multi-center RCT comparing cisplatin or carboplatin + 5-FU with methotrexate, a significantly better response was observed rate for the combination arms, though median survival and duration of response were unchanged. 59 Response rates in studies comparing triple-drug regimens such as cisplatin or carboplatin + ifosfamide + paclitaxel or cisplatin + 5-FU + docetaxel have been as high as 60%, even in pretreated patients, with median of survival of 9-11 months.…”