Concomitant chemoradiotherapy using low-dose weekly gemcitabine versus low-dose weekly paclitaxel in locally advanced head and neck squamous cell carcinoma: a phase III study

Abstract

The objective of this study was to compare concomitant chemoradiotherapy based on weekly low-dose gemcitabine versus weekly low-dose paclitaxel in locally advanced head and neck squamous cell carcinoma. Previously, untreated patients with locally advanced squamous cell carcinoma of the head and neck were randomly assigned to one of the two concomitant chemoradiation regimens: (1) weekly gemcitabine at a dose of 100 mg/m(2) over 30 min 1-2 h before radiotherapy and (2) weekly paclitaxal at a dose of 20 mg/m(2) over 60 min 4-6 h before radiotherapy. The planned radiotherapy dose was 65 Gy over 6.5 weeks in 32 settings. Two hundred and sixteen patients were randomly divided into 2 groups: group A (110 patients) and group B (106 patients) who received concomitant weekly low-dose gemcitabine and low-dose paclitaxal, respectively, with the radiotherapy protocol. The hematological toxicity was generally mild. On the contrary, non-hematologic toxicities were severe. Grade III mucositis occurred in 36% in group A and in 24% in group B (P = 0.04). Moreover, grade III dermatitis were encountered in 24% in group A and 13% in group B (P = 0.049). Thirty-two (29%) of group A and 18(17%) of group B patients required enteral or parenteral feeding (P = 0.01). Sixteen (15%) of group A and 6 (6%) of group B required enteral or parenteral feeding that lasted for 6 months (P = 0.03). Regarding the late effect on swallowing, 8% of patients in group A and 2% of patients in group B required enteral or parenteral feeding for more than 6 months (P = 0.035). Response rates were 78 and 89% in groups A and B, respectively (P = 0.038). The 2-year progression-free survival figures were 54 and 64% of groups A and B, respectively; however, the 2-year overall survival figures were 56 and 67%, respectively. On the other hand, the 3-year progression-free survival figures were 39 and 48% for groups A and B, respectively, while the 3-year overall survival figures were 45 and 49%, respectively (P = 0.05). Both concomitant chemoradiotherapy regimens were easily given in the outpatient clinic. The regimen based on paclitaxel was significantly more tolerable and effective; however, the difference was not enormous.

Concomitant chemoradiotherapy versus altered fractionation radiotherapy in the radiotherapeutic management of locoregionally advanced head and neck squamous cell carcinoma: An adjusted indirect comparison meta-analysis

“…Several randomized trials have since been updated and new trials reported in the indexed medical literature that were not considered in the present analysis. Some of these have used newer and more potent chemotherapeutic agents or targeted therapy concurrently with RT that may further enhance the efficacy of the concomitant regimen. In parallel, some recent reports of altered fractionation RT have also demonstrated much larger survival benefit than was demonstrated by the MARCH meta‐analysis and are being included in an updated meta‐analysis of altered fractionation (MARCH 2).…”

Definitive radiochemotherapy of advanced head and neck cancer with carboplatin and paclitaxel

“…Paclitaxel -representative of the second generation chemotherapy -has been used in SCCHN single-agent [7,14] or platinum-based radiochemotherapy protocols [2,6,8,15,22,25]. Current treatment strategies often use hyperfractionated or hyperfractionated-accelerated radiotherapy protocols to enhance efficacy.…”

Re-irradiation with 36 Gy (1.5 Gy Twice Daily) Plus Paclitaxel for Advanced Recurrent and Previously Irradiated SCCHN is Feasible

“…Cisplatin, the most common agent, may lead to significant side effects and cannot be used in many patients with recurrent SCCHN (7). Beside other systemic treatments, paclitaxel may be an alternative option for these patients, which has been reported to be effective and associated with favorable toxicity profiles (8)(9)(10). For example, in a prospective study of 35 patients with locally advanced SCCHN, 70.2-72 Gy of radiotherapy plus three courses of paclitaxel resulted in a median survival of 56.5 months, and most toxicities were grade 2 or less (9).…”

“…However, many patients, particularly in recurrent disease after chemoradiation, may not be able to receive platin-based chemotherapy again due to expected toxicity such as nausea, vomiting and renal failure (7). For these patients, taxanes may be an alternative option, since these agents have been proved effective as a monotherapy in patients with SCCHN (8)(9)(10). In addition to concurrent chemotherapy, twice-daily administration of radiotherapy with lower doses per fraction (e.g.…”