Combined Radiochemotherapy with Docetaxel in Patients with Unresectable Locally Advanced Head and Neck Tumors

Hesse, Katja; Heinrich, Bernhard; Zimmermann, Frank; Kau, Reinhard; Sommer, Gabriele; Achterrath, W.; Molls, M.; Feldmann, Horst Jürgen

doi:10.1007/pl00002330

Cited by 22 publications

(14 citation statements)

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“…38,39 Although a number of trials have examined the use of docetaxel as part of multiagent treatment regimens for the treatment of patients with SCCHN at the time of initial presentation or for recurrent disease, only two trials have examined concurrent docetaxel with radiation. 21,42 One study examined concurrent weekly docetaxel plus irinotecan with radiation to a total dose of 66 -70 Gy. 42 The MTD consisted of 20 mg/m 2 for docetaxel and 55 mg/m 2 for irinotecan.…”

Section: Discussionmentioning

confidence: 99%

“…In contrast with this result, a study of docetaxel as a single agent in patients with Stage IV SCCHN had multiple DLTs (two Grade 4 skin reactions, two Grade 4 pulmonary toxicities, and one Grade 3 thrombocytopenia among 6 patients) at the initial weekly dose of 15 mg/m 2 . 21 The reason for the failure of that trial even to complete the first dose level is not clear.…”

Section: Discussionmentioning

confidence: 99%

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A Phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck

Tishler

Norris

Colevas

et al. 2002

Cancer

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BACKGROUNDThe authors conducted a Phase I/II study in patients with a poor prognosis who had locally advanced squamous cell carcinoma of the head and neck (SCCHN) and who were treated initially with induction chemotherapy. Patients were treated with weekly docetaxel and concurrent daily fractionated radiation therapy to determine the maximum tolerated dose (MTD) of docetaxel and the efficacy of the regimen.METHODSTwenty‐two patients were enrolled, and 21 patients were treated. Eight patients had Stage III SCCHN, and 13 patients had Stage IV SCCHN without distant metastases and were treated first with 2‐3 cycles of induction chemotherapy, which consisted of cisplatin plus 5‐fluorouracil with or without leucovorin. Patients with a poor prognosis were identified as those who achieved a partial response to induction treatment, achieved a complete response with a positive biopsy, or were at high risk for developing recurrent disease. Patients were treated subsequently with concurrent, escalating doses of docetaxel (given weekly × 6) and once daily 200‐centigray radiation fractions.RESULTSThree patients were treated with a weekly docetaxel dose of 20 mg/m2 without dose‐limiting toxicity (DLT). Both patients who were treated at the next dose level of 30 mg/m2 experienced DLT. A dose of 25 mg/m2 was studied without DLT in the 16 patients who were treated, establishing this as the MTD. Sixty‐seven percent of the patients are alive without disease at a median follow‐up of 35 months (range, 12–59 months) after the initiation of chemoradiotherapy.CONCLUSIONSThe MTD of weekly docetaxel with concurrent daily radiation therapy in the postinduction setting was 25 mg/m2. Disease free survival data from this study were good and indicated that this regimen was effective in the treatment of patients with SCCHN who had a poor prognosis. Cancer 2002;95:1472–81. © 2002 American Cancer Society.DOI 10.1002/cncr.10873

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A Phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck

Tishler

Norris

Colevas

et al. 2002

Cancer

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“…The activity of docetaxel in SCCHN, coupled with the drug's in vitro radiosensitizing properties (Creane et al, 1999;Mason et al, 1999;Pradier et al, 2001), provide the basis for clinical trials with docetaxel as a component of concurrent or alternating chemoradiation in locally advanced SCCHN (Koukourakis et al, 1999;Hesse et al, 2000;Tishler et al, 2002). Docetaxel-based chemoradiation regimens have been shown to be feasible and active as induction and adjuvant therapy.…”

Section: Docetaxel-based Chemoradiation Regimens For Locally Advancedmentioning

confidence: 99%

Docetaxel induction therapy in locally advanced squamous cell carcinoma of the head and neck

Posner

Lefèbvre

2003

Br J Cancer

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Patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) are often treated with induction chemotherapy or chemoradiotherapy, but to date without major impact on survival. The combination of cisplatin -5-fluorouracil (5-FU) (PF) has been used as standard induction therapy; however, poor patient survival has stimulated investigation into new agents with potential activity in SCCHN. Docetaxel has significant single-agent activity in SCCHN and has been investigated in combination with PF regimens as induction therapy. The results of six phase II studies of docetaxel -PF regimens (TPF) as induction in locally advanced SCCHN patients are reviewed and reported. Consistently, high 2-year survival rates and overall response rates were demonstrated across the phase II trials in the range 42 -82 and 71 -100%, respectively. The toxicity profile seen with TPF-based regimens was acceptable. The primary toxicity was neutropenia, which together with gastrointestinal complaints accounted for the majority of adverse events. Given the encouraging phase II experience with TPF-based regimens, two large-scale phase III studies comparing TPF-based regimens with standard PF regimens are underway. The results have significant potential for validating the findings of the phase II studies, demonstrating improved survival and overall response of patients treated with docetaxel-based induction chemotherapy.

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“…Notably, a fluid retention syndrome is known to occur in as many as 20%-60% of nonpremedicated patients treated with the agent, but this is typically peripheral, with pleural effusions reported only occasionally [63][64][65]. Although no NCPE has been attributed to docetaxel as a single agent to date, several cases have been reported with its combination with gemcitabine and radiotherapy [8,66,67]. Vinblastine as a single agent has anecdotally been associated with the development of NCPE [68], but this toxicity seems to occur more often when combined with mitomycin [69][70][71].…”

Section: Cytotoxic Drugsmentioning

confidence: 99%

Noncardiogenic Pulmonary Edema: An Unusual and Serious Complication of Anticancer Therapy

Briasoulis

Pavlidis

2001

The Oncologist

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Noncardiogenic pulmonary edema (NCPE) is a rare and less well-recognizable pulmonotoxic syndrome of anticancer therapy than pneumonitis/fibrosis. NCPE is a clinical syndrome characterized by simultaneous presence of severe hypoxemia, bilateral alveolar infiltrates on chest radiograph, and no evidence of left atrial hypertension/congestive heart failure. The diagnosis of drug-related NCPE relies upon documented exclusion of any infectious, metabolic, or cancer-related causes. The Oncologist 2001;6:153-161 www.TheOncologist.com Correspondence: Evangelos Briasoulis, M.D., Medical Oncology Department, Ioannina University, Ioannina, 45110, Greece. Telephone and Fax: 30-651-99394; e-mail: ebriasou@otenet.gr. Received August 15, 2000; accepted for publication November 30, 2000. ©AlphaMed Press 1083-7159/2001 INTRODUCTIONSeveral cancer therapeutic drugs are known to induce pulmonary damage, which may result in a variety of clinicopathologic syndromes with minor to severe clinical consequences [1]. Clinical syndromes associated with drug-induced pulmonary toxicity include pneumonitis/fibrosis, hypersensitivity lung disease, and noncardiogenic pulmonary edema (NCPE)/acute respiratory distress syndrome (ARDS). These syndromes share a similar symptomatology but differ in regard to the time-relation to cancer treatment, the radiographic findings, the duration of pulmonary damage, and the long-term outcome [2]. Non-specific symptomatology of cough, progressive dyspnea, and often a low-grade fever alert clinicians confronted with the diagnostic challenge to recognize subclinical syndromes and differentiate fully developed drug-induced pulmonary reactions from lung injuries caused by infectious, cardiac, and neoplastic causes.

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Combined Radiochemotherapy with Docetaxel in Patients with Unresectable Locally Advanced Head and Neck Tumors

Abstract: Unexpectedly already in the first dose level several dose limiting toxicities were evaluated. For that reason the treatment scheme is not feasible.

Cited by 22 publications

References 32 publications

A Phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck

A Phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck

Docetaxel induction therapy in locally advanced squamous cell carcinoma of the head and neck

Noncardiogenic Pulmonary Edema: An Unusual and Serious Complication of Anticancer Therapy

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