Aggressive simultaneous radiochemotherapy with cisplatin and paclitaxel in combination with accelerated hyperfractionated radiotherapy in locally advanced head and neck tumors. Results of a phase I-II trial.
Identifieur interne : 004147 ( PubMed/Corpus ); précédent : 004146; suivant : 004148Aggressive simultaneous radiochemotherapy with cisplatin and paclitaxel in combination with accelerated hyperfractionated radiotherapy in locally advanced head and neck tumors. Results of a phase I-II trial.
Auteurs : Thomas Kuhnt ; Axel Becker ; Steffi Pigorsch ; Tanja Pelz ; Marc Bloching ; Marcus Passmann ; Erwin Lotterer ; Gabriele H Nsgen ; Jürgen DunstSource :
- Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] [ 0179-7158 ] ; 2003.
English descriptors
- KwdEn :
- Adult, Aged, Antineoplastic Agents (administration & dosage), Antineoplastic Agents (adverse effects), Antineoplastic Agents (therapeutic use), Antineoplastic Agents, Phytogenic (administration & dosage), Antineoplastic Agents, Phytogenic (therapeutic use), Cisplatin (administration & dosage), Cisplatin (adverse effects), Cisplatin (therapeutic use), Cohort Studies, Combined Modality Therapy, Dose Fractionation, Female, Follow-Up Studies, Head and Neck Neoplasms (drug therapy), Head and Neck Neoplasms (mortality), Head and Neck Neoplasms (radiotherapy), Humans, Hypopharyngeal Neoplasms (drug therapy), Hypopharyngeal Neoplasms (mortality), Hypopharyngeal Neoplasms (radiotherapy), Laryngeal Neoplasms (drug therapy), Laryngeal Neoplasms (mortality), Laryngeal Neoplasms (radiotherapy), Male, Middle Aged, Mouth Mucosa (drug effects), Mouth Neoplasms (drug therapy), Mouth Neoplasms (mortality), Mouth Neoplasms (radiotherapy), Neoplasm Metastasis, Oropharyngeal Neoplasms (drug therapy), Oropharyngeal Neoplasms (mortality), Oropharyngeal Neoplasms (radiotherapy), Paclitaxel (administration & dosage), Paclitaxel (adverse effects), Paclitaxel (therapeutic use), Radiotherapy Dosage, Stomatitis (chemically induced), Survival Analysis, Time Factors.
- MESH :
- chemical , administration & dosage : Antineoplastic Agents, Antineoplastic Agents, Phytogenic, Cisplatin, Paclitaxel.
- chemical , adverse effects : Antineoplastic Agents, Cisplatin, Paclitaxel.
- chemical , therapeutic use : Antineoplastic Agents, Antineoplastic Agents, Phytogenic, Cisplatin, Paclitaxel.
- chemically induced : Stomatitis.
- drug effects : Mouth Mucosa.
- drug therapy : Head and Neck Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Oropharyngeal Neoplasms.
- mortality : Head and Neck Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Oropharyngeal Neoplasms.
- radiotherapy : Head and Neck Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Oropharyngeal Neoplasms.
- Adult, Aged, Cohort Studies, Combined Modality Therapy, Dose Fractionation, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Metastasis, Radiotherapy Dosage, Survival Analysis, Time Factors.
Abstract
Simultaneous radiochemotherapy (sRCT) is the treatment of first choice in locally advanced head and neck cancers. We have tested a very aggressive combination protocol with cisplatin and escalated paclitaxel in combination with accelerated hyperfractionated radiotherapy to assess the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), overall toxicity, and response rate.
DOI: 10.1007/s00066-003-1106-0
PubMed: 14566475
Links to Exploration step
pubmed:14566475Le document en format XML
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<front><div type="abstract" xml:lang="en">Simultaneous radiochemotherapy (sRCT) is the treatment of first choice in locally advanced head and neck cancers. We have tested a very aggressive combination protocol with cisplatin and escalated paclitaxel in combination with accelerated hyperfractionated radiotherapy to assess the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), overall toxicity, and response rate.</div>
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<DateCreated><Year>2003</Year>
<Month>10</Month>
<Day>20</Day>
</DateCreated>
<DateCompleted><Year>2003</Year>
<Month>11</Month>
<Day>17</Day>
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<DateRevised><Year>2015</Year>
<Month>11</Month>
<Day>19</Day>
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<JournalIssue CitedMedium="Print"><Volume>179</Volume>
<Issue>10</Issue>
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<Month>Oct</Month>
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<Title>Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]</Title>
<ISOAbbreviation>Strahlenther Onkol</ISOAbbreviation>
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<ArticleTitle>Aggressive simultaneous radiochemotherapy with cisplatin and paclitaxel in combination with accelerated hyperfractionated radiotherapy in locally advanced head and neck tumors. Results of a phase I-II trial.</ArticleTitle>
<Pagination><MedlinePgn>673-81</MedlinePgn>
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<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Simultaneous radiochemotherapy (sRCT) is the treatment of first choice in locally advanced head and neck cancers. We have tested a very aggressive combination protocol with cisplatin and escalated paclitaxel in combination with accelerated hyperfractionated radiotherapy to assess the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), overall toxicity, and response rate.</AbstractText>
<AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">The trial recruited 24 patients (21 males, three females, mean age 57 years) treated at our department from 1998 through 2001. Irradiation was administered in daily doses of 2 Gy up to 30 Gy followed by 1.4 Gy twice daily up to 70.6 Gy to the primary tumor and involved nodes and 51 Gy to the clinically negative regional nodes. The chemotherapy schedule included cisplatin in a fixed dose of 20 mg/m(2) on days 1-5 and 29-33 and paclitaxel at increasing dose levels of 20, 25, 30 mg/m(2) twice weekly over the whole treatment time. Patients were recruited in cohorts of three to six, and the MTD was reached if two out of six patients in one cohort developed DLT. DLT was defined as any grade 4 toxicity or any grade 3 toxicity requiring treatment interruption or unplanned hospitalization or any grade 3 neurotoxicity. We recruited mainly patients with large tumors for this protocol; all patients were stage IV, and the mean tumor volume (primary + metastases) amounted to 72 +/- 61 cm(3). The mean follow-up was 30 months (range 4-39 months).</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">One early death (peritonitis and sepsis at day 10) occurred, and 23 patients were evaluable for acute toxicity and response. The MTD of paclitaxel was reached at the third dose level (30 mg/m(2) paclitaxel twice weekly). The DLT was severe mucositis grade 3 (n = 1) and skin erythema grade 4 (n = 2). After determining the MTD, another 14 patients were treated at the recommended dose level of paclitaxel with 25 mg/m(2) twice weekly. In summary, 13/23 patients (57%) developed grade 3 and 10/23 (43%) grade 2 mucositis. Two patients (9%) had grade 4, five (22%) grade 3, and 16 (69%) grade 2 dermatitis. One patient died at day 30 of neutropenic infection. In one patient, a grade 2 nephrotoxicity appeared requiring cessation of cisplatin chemotherapy. 18/23 patients (78%) required blood transfusion (1-3 units) and 16/23 (70%) i.v. antibiotics. 14 patients (61%) achieved a complete and nine (39%) a partial remission, yielding an overall response rate of 100%. In summary, six patients died of local tumor progression (n = 2), distant metastases (n = 2), or therapy-related complications (n = 2) during follow-up. The 3-year overall survival was 71%. Tumor volume was not a risk factor for failure in this protocol (mean tumor volume in relapse-free vs. progressive patients 71 +/- 65 cm(3) vs. 64 +/- 38 cm(3)). All patients have, so far, developed only slight late effects (fibrosis, lymphedema) with no grade 3-4 late sequelae.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">This very aggressive sRCT protocol yielded excellent response and survival figures but was associated with a very high rate of acute toxicity (8% therapy-related deaths). A maximal supportive treatment is therefore required.</AbstractText>
</Abstract>
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