Chemotherapy in head and neck cancer

Jp, Armand; Couteau, C.

doi:10.1016/0959-8049(95)00124-2

Cited by 12 publications

(7 citation statements)

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“…Postradiation or postoperative adjuvant chemotherapy seldom is tried because compromised vasculature, caused by radiation change or ablative surgery, will reduce drug penetration and the effectiveness of chemotherapy. The majority of clinical trials involve either neoadjuvant or concomitant chemotherapy for advanced SCCHN 3–6, 9–45. In general, the disadvantages of neoadjuvant chemotherapy include delayed primary treatment in nonresponders, refusal of further curative therapy in responders, triggering of accelerated repopulation of surviving clonogens,48 and cross‐resistance to further radiotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…Oncologists have sought to improve local control and survival by combining chemotherapy with standard treatment in patients with advanced solid tumors 7–10. Both neoadjuvant chemotherapy (before surgery or radiotherapy) and concomitant chemotherapy (with radiotherapy) for head and neck tumors have been studied extensively during recent years 3–6, 9–45. However, there still is great controversy regarding the optimal timing, dosage, and contribution of chemotherapy to increase curability.…”

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High rate of clinical complete response to weekly outpatient neoadjuvant chemotherapy in oral carcinoma patients using a new regimen of cisplatin, 5-fluorouracil, and bleomycin alternating with methotrexate and epirubicin

Lin

Jan

Hsu

et al. 1999

Cancer

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BACKGROUND A Phase II trial was initiated to evaluate the response to and toxicity of a new regimen of weekly outpatient neoadjuvant chemotherapy in patients with oral carcinoma. METHODS Patients with previously untreated squamous cell carcinoma of the oral cavity were eligible for this trial. The neoadjuvant chemotherapy was comprised of cisplatin, 25 mg/m2, 5‐fluorouracil, 1000 mg/m2, and bleomycin, 10 mg/m2, mixed in normal saline as a 24‐hour intravenous (i.v.) infusion, alternating with methotrexate, 30 mg/m2, and epirubicin, 30 mg/m2, as an i.v. bolus (PFB/ME) on a weekly schedule for 8–12 weeks. In patients with American Joint Committee on Cancer Stage IV disease who completed neoadjuvant chemotherapy, surgery was preferred to radiotherapy, unless patients refused surgery. RESULTS A total of 40 patients (82.5% with Stage IV disease) with previously untreated oral carcinoma were enrolled. The median size of the primary tumor was 7 cm (range, 3–13 cm). Fifty percent of patients had tumor penetrating through the oral mucosa to the cheek skin and 62.5% had bony destruction. Detectable cervical lymph nodes were noted in 77.5% of patients. After neoadjuvant weekly chemotherapy, 22 patients (55%) showed complete response (CR) and 15 patients (37.5%) showed partial response, for an overall response rate of 92.5%. World Health Organization Grade 3/4 toxicity included mucositis (7.5%), leukopenia (25%), anemia (10%), and thrombocytopenia (2.5%). Eleven of 33 patients with Stage IV disease underwent surgery, and pathologic CR (2 patients) or microscopic residual tumor (4 patients) was noted (54.5%). CONCLUSIONS The results of the current study indicate that a weekly PFB/ME neoadjuvant chemotherapy regimen is highly effective for the treatment of patients with oral carcinoma. In addition, this regimen has low toxicity. The authors believe that implementation of this regimen into a multimodality therapy protocol deserves further study. Cancer 1999;85:1430–8. © 1999 American Cancer Society.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

High rate of clinical complete response to weekly outpatient neoadjuvant chemotherapy in oral carcinoma patients using a new regimen of cisplatin, 5-fluorouracil, and bleomycin alternating with methotrexate and epirubicin

Lin

Jan

Hsu

et al. 1999

Cancer

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“…3)) is used in an attempt to catch microscopic tumour residues after a surgical and/or radiotherapeutic intervention has been carried out. Despite impressive remission rates, mainly with inductive CTX, no reliable improvement in survival time has so far been demonstrated using adjuvant CTX alone [163], [91], [68], [109], [15]. Adjuvant CTX is most effectively used in combination with irradiation therapy in the form of adjuvant CRT (see the paper by F. Wenz).…”

Section: Cytostaticsmentioning

confidence: 99%

Systemic therapy strategies for head-neck carcinomas: Current status

Hoffmann¹

2012

GMS Current Topics in Otorhinolaryngology - Head and Neck Surgery; 11:Doc03; ISSN 1865-1011

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“…The use of chemotherapy after locoregional treatment has been studied in only a limited number of randomized trials in HNSCC. Early studies examining the impact of chemotherapy in the maintenance setting demonstrated modest, but minimal, benefits, and these did not translate into a survival benefit overall [ 18 – 20 ]. A significant survival advantage was seen only in a subgroup of patients with N2 disease in a subset analysis of the Head and Neck Contracts Programme, suggesting that maintenance chemotherapy may only be appropriate for patients with advanced disease [ 18 ].…”

Section: Introductionmentioning

confidence: 99%

Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial

Burtness

Bourhis

Vermorken

et al. 2014

Trials

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BackgroundOver 50% of patients with head and neck squamous cell carcinoma (HNSCC) present with locoregionally advanced disease. Those at intermediate-to-high risk of recurrence after definitive therapy exhibit advanced disease based on tumour size or lymph node involvement, non-oropharynx primary sites, human papillomavirus (HPV)-negative oropharyngeal cancer, or HPV-positive oropharynx cancer with smoking history (>10-pack-years). Non-surgical approaches include concurrent chemoradiotherapy, induction chemotherapy followed by definitive radiotherapy or chemoradiotherapy, or radiotherapy alone. Following locoregional therapies (including surgical salvage of residual cervical nodes), no standard intervention exists. Overexpression of epidermal growth factor receptor (EGFR), an ErbB family member, is associated with poor prognosis in HNSCC. EGFR-targeted cetuximab is the only targeted therapy that impacts overall survival and is approved for HNSCC in the USA or Europe. However, resistance often occurs, and new approaches, such as targeting multiple ErbB family members, may be required. Afatinib, an irreversible ErbB family blocker, demonstrated antiproliferative activity in preclinical models and comparable clinical efficacy with cetuximab in a randomized phase II trial in recurrent or metastatic HNSCC. LUX-Head & Neck 2, a phase III study, will assess adjuvant afatinib versus placebo following chemoradiotherapy in primary unresected locoregionally advanced intermediate-to-high-risk HNSCC.Methods/designPatients with primary unresected locoregionally advanced HNSCC, in good clinical condition with unfavourable risk of recurrence, and no evidence of disease after chemoradiotherapy will be randomized 2:1 to oral once-daily afatinib (40 mg starting dose) or placebo. As HPV status will not be determined for eligibility, unfavourable risk is defined as non-oropharynx primary site or oropharynx cancer in patients with a smoking history (>10 pack-years). Treatment will continue for 18 months or until recurrence or unacceptable adverse events occur. The primary endpoint measure is duration of disease-free survival; secondary endpoint measures are disease-free survival rate at 2 years, overall survival, health-related quality of life and safety.DiscussionGiven the unmet need in the adjuvant treatment of intermediate-to-high-risk HNSCC patients, it is expected that LUX-Head & Neck 2 will provide new insights into treatment in this setting and might demonstrate the ability of afatinib to significantly improve disease-free survival, compared with placebo.Trial registrationClinicalTrials.gov NCT01345669.Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-469) contains supplementary material, which is available to authorized users.

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Chemotherapy in head and neck cancer

Cited by 12 publications

References 0 publications

High rate of clinical complete response to weekly outpatient neoadjuvant chemotherapy in oral carcinoma patients using a new regimen of cisplatin, 5-fluorouracil, and bleomycin alternating with methotrexate and epirubicin

High rate of clinical complete response to weekly outpatient neoadjuvant chemotherapy in oral carcinoma patients using a new regimen of cisplatin, 5-fluorouracil, and bleomycin alternating with methotrexate and epirubicin

Systemic therapy strategies for head-neck carcinomas: Current status

Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial

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