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) … Show more
“…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).…”
Concomitant CRT and hyperfractionated RT are comparable to one another on indirect comparison in the radiotherapeutic management of locoregionally advanced HNSCC. Any form of acceleration (with or without total dose reduction) may not compensate fully for lack of chemotherapy.
“…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).…”
Concomitant CRT and hyperfractionated RT are comparable to one another on indirect comparison in the radiotherapeutic management of locoregionally advanced HNSCC. Any form of acceleration (with or without total dose reduction) may not compensate fully for lack of chemotherapy.
“…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.…”
“…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).…”
Section: Discussionmentioning
confidence: 99%
“…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.…”
Abstract. Background About half the patients who were treated for advanced nonmetastatic squamous cell carcinoma of the head and neck (SCCHN) develop a loco-regional recurrence either at the primary tumor site and/or in regional lymph nodes (1-3). In case of such a recurrence, a complete resection is often not safely possible, and the patients are referred to radiotherapy, ideally combined with concurrent chemotherapy (4). However, many of these patients had already received 60-70 Gy of radiotherapy (usually with 5 daily fractions of 2 Gy per week) as part of their primary treatment, either as a definitive or an adjuvant approach. For the treatment of a loco-regional recurrence, the second course of radiotherapy cannot be safely administered with 60-70 Gy again when taking into account the tolerance doses of the organs at risk in the head and neck region (5). This problem may be partly overcome with the addition of concurrent chemotherapy, which can be assumed to represent more than additional 10% of the radiotherapy dose regarding the effect of tumor cell kill (6). Cisplatin and carboplatin are the most commonly used agents for SCCHN. 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 (8-10). In addition to concurrent chemotherapy, twice-daily administration of radiotherapy with lower doses per fraction (e.g. of 1.5 Gy) is a relatively novel approach to improve treatment outcome in such coditions. The risk of late radiation morbidity can be decreased with the use of lower doses per fraction (11). Normal tissues can recover from radiotherapy after 6 to 8 hours, whereas tumor cells generally do not recover. We followed this approach in a previous report of patients receiving mainly 30 Gy of radiotherapy with two daily fractions of 1.5 Gy supplemented by 20-25 mg/m 2 of paclitaxel administered twice weekly (12). However, the question arose whether a better outcome could be achieved with a higher radiation dose than 30 Gy. Therefore, we increased the total radiation dose to 36 Gy in the present series and investigated the feasibility and efficacy of this regimen.
Patients and MethodsFour patients with head-and-neck cancer, two women and two men, underwent this therapy regimen. These patients had developed an advanced loco-regional recurrence of SCCHN following surgery plus postoperative platin-based chemoradiation. Two patients had oropharynx cancer, one patient cancer of the oral cavity and one 519
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