Combined postoperative radiotherapy and weekly cisplatin infusion for locally advanced squamous cell carcinoma of the head and neck: Preliminary report of a randomized trial

Bachaud, J.M.; David, Jean-Marc; Boussin, G.; Daly, N

doi:10.1016/0360-3016(91)90098-o

Cited by 116 publications

(62 citation statements)

References 13 publications

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“…Their third treatment arm consisted of RT alone and resulted in significantly worse locoregional control. In postoperative therapy Bachaud [7] found a significant benefit for simultaneous cisplatin given once per week up to a cumulative dose of 350-450 mg absolute. For patients with high nodal stage, the risk to develop distant metastasis was impressively high (60% after 4 years for pN2c and pN3).…”

Section: Discussionmentioning

confidence: 99%

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Postoperative Irradiation for Squamous Cell Carcinoma ofHead and Neck: Retrospective Comparison of Accelerated Radiochemotherapy and Standard Radiotherapy

Panzer¹,

Busch²,

Kiszel³

et al. 2000

Oncol Res Treat

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Background: Comparison of accelerated radiochemotherapy (aRCT) and standard radiotherapy (sRT) in postoperative treatment after macroscopically complete resection of squamous cell cancers of head and neck. Material and Methods: 229 patients treated within the same period had either (no randomization) postoperative radiotherapy with conventional fractionation (60–70 Gy, 2.0 Gy per day) or received 2 fractions of 2.1 Gy per day, 8 times/week, up to a total dose of 56.7 Gy with a treatment split after 2 weeks and simultaneous low dose cisplatin or carboplatin on treatment days (cumulative dose > 66 mg/m² or 550 mg/m² in 83% of patients). Results: 65 patients completed their course of twice-daily irradiations within a maximum of 35 days and therefore had aRCT; their 3-year locoregional tumor control (Kaplan-Meier estimate) was 86%, whereas that of 42 patients with prolonged twice-daily radiochemotherapy was 65% (p = 0.0509). After sRT, i.e. 1 fraction daily and treatment time up to 45 days, locoregional tumor control was 67%, this result being significantly inferior to that after aRCT (p = 0.0282). In multivariate analysis, pN stage, tumor site oral cavity/floor of mouth, high/moderate differentiation of squamous cell carcinoma and conventional surgery (versus CO₂-laser surgery) were significantly predictive of locoregional failure. Whereas nodal status, the strongest prognostic factor, was evenly distributed among aRCT and sRT patients, there was a misbalance of 3 risk factors favoring the aRCT collective. Superior tumor control after aRCT was confirmed unilaterally for nearly each subgroup (significant for recurrent tumors, close margins, pN1/2a-b). For pN2c/pN3 nodal stage, the results after aRCT were by tendency worse than after sRT, possibly due to a particularly long interval between surgery and start of radio(chemo)therapy for the patients with aRCT (mean 58.0 days vs. 43.8 days, p = 0.037). Among the total of patients the 3-year hazard for late toxicity III–IV was 31% after twice-daily treatment and 17% after conventionally fractionated radiotherapy (p = 0.083). Conclusions: This retrospective analysis provides some evidence that accelerated radiotherapy with simultaneous chemotherapy is more potent than standard radiotherapy. However, as multivariate analysis misses significance and the influence of misbalance of some prognostic factors among aRCT and sRT patients remains unclear, only a randomized trial with stratification according to risk factors as well as a defined interval between surgery and initiation of RT can provide more evidence.

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Section: Discussionmentioning

confidence: 99%

“…In order to improve the results especially of high-risk patients, other modes of treatment intensification have to be tested. Simultaneous chemotherapy with mitomycin C [6] or cisplatin [7] resulted in significantly better locoregional control. Recent considerations on tumor biology focus on the time factor [8].…”

Section: Introductionmentioning

confidence: 99%

Postoperative Irradiation for Squamous Cell Carcinoma ofHead and Neck: Retrospective Comparison of Accelerated Radiochemotherapy and Standard Radiotherapy

Panzer¹,

Busch²,

Kiszel³

et al. 2000

Oncol Res Treat

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“…[3][4][5] Head and neck radiation may be applied as a palliative or curative measure. 1 Collateral damage may occur to tissues adjacent to the irradiated malignancy [6][7][8] as normal tissue is frequently in the path of the radiation beam.…”

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confidence: 99%

An Investigation into the Use of Pilocarpine as a Sialagogue in Patients With Radiation Induced Xerostomia

Frydrych

Davies

Slack‐Smith

et al. 2002

Australian Dental Journal

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Background: Radiation therapy to the head and neck region can be an effective form of treatment for malignancies. Unfortunately damage to salivary glands may occur. Treatment of resultant dry mouth is at present very poor. The purpose of this pilot study was to investigate whether pilocarpine dissolved in artificial saliva and administered in a mouth spray would be effective in relieving such symptoms. Methods: Twenty-three patients with radiation induced hyposalivation were recruited for this randomized, double-blind investigation. Subjects were randomly allocated to placebo or control medicaments used for eight weeks. All subjects were evaluated for the severity of their xerostomia associated symptoms prior to administration of the spray and again eight weeks later. Results: The questionnaire and the visual analogue scale did not reveal any improvements in the dry mouth symptoms between cases and controls. Sideeffects were reported among cases, mostly mild and tolerable. All patients taking pilocarpine (with base salivary flow rates > 0ml/min) demonstrated improvement in stimulated and unstimulated salivary flow rates. Candida counts decreased among the cases and controls although decrease among the cases was much greater. Conclusions:The results obtained indicate that provided residual functioning salivary tissue exists, pilocarpine used as formulated is effective and warrants further investigation.

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“…Regimens of mitomycin, 5-FU, methotrexate, and bleomycin in combination with radiotherapy have shown efficacy superior to that of radiotherapy alone in the treat ment of advanced head and neck carcinomas [3,5,8], Cisplatin/radiotherapy achieved even better results, com pared with irradiation alone in a randomized study of high-risk postoperative patients [2], To develop a treat ment of similar activity but less toxicity, several phase I studies were carried out in which carboplatin and simulta neous radiotherapy were given to patients with advanced head and neck carcinoma; the results indicated compara ble efficacy to that reported with cisplatin and cisplatin/ 5-FU regimens in combination with radiotherapy [12,13].…”

Section: Discussionmentioning

confidence: 99%

“…Radiochemotherapy is gaining importance as primary treatment [1]. Mitomycin, 5-fluorouracil (5-FU), bleomy cin, methotrexate, and platinum derivatives have been used simultaneously with radiotherapy and have proven to be effective [2][3][4][5][6][7][8][9][10], Unfortunately, some of these agents enhance mucosal reactions of concomitant radiotherapy [3,9], In contrast, platinum derivatives do not enhance mucositis [10,11]. We report our experience using con ventional and hyperfractionated accelerated radiotherapy in combination with carboplatin in the management of advanced head and neck carcinomas.…”

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confidence: 99%

Combined Radiochemotherapy with Carboplatin in the Treatment of Advanced Head and Neck Carcinomas

Schnabel

Zamboglou²,

Kolotas³

et al. 1993

Oncology

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From 1987 to 1991, 100 evaluable patients with advanced head and neck carcinomas (T2–4, N0–3) were treated with radiotherapy and simultaneous carboplatin. Tumors were located in the oral cavity in 33 patients, oropharynx in 8 patients, and hypopharynx in 7 pateints. four patients had a tumor of the epipharynx, 3 of the larynx, and 45 had involvement of two or more compartments. radiotherapy was performed in a fractionation of 5 × 2 Gy/week up to a dose of 50 Gy. Carboplatin was administered in a dose of 60 or 70 mg/m² from days 1–5 qand 20–33. After a 2-week interval, tumor in invlution was evaluated and a decision was made on the patients’ operability. In cases of inoperability, radiotherapy was continued up to a dose of 70–74 Gy. thirty patients underwent surgery after 50 Gy. Eight patients showed a histologically complete remission (CR), 7 showed microscopic residual tumor, and 15 showed macroscopic tumor. Seventy patients were treated with radiotherapy and concomitant carboplatin only. Thirty-nine of them achieved a CR and 30 a partial remission (PR). The residual tumor was operable in 8 of the latter patients. Only a minor response was achieved in the remaining patient At the end of the treatment 77 patients achieved a CR with this combined modality. From 1990 to 1992, 20 patients with locally advanced head and neck carcinomas underwent hyperfractionated accelerated radiotherapy (2 × 1.6 Gy/day, 5 days per week; total dose, 64–67.2 Gy) and simultaneous intravenous carboplatin (60 mg/m², days 1–5 and 29–33) in a pilot study. Fifteen patients had T4 and 5 had T3 tumors. Six weeks after the end of treatment, 16 patients (80%) had CR, and PR was seen in the other 4 patients (20%). Overall and disease-free survival at 1 year was 82 and 81%, respectively. Although acute side effects were more pronounced compared with conventional irradiation, this treatment regimen is feasible and the initial CR rate 80% is encouraging. Because of the results achieved with hyperfractionated accelerated radiotherapy, we initiated a multicenter randomized study in November 1991. Patients with advanced head and neck carcinomas are either randomized for conventional radiotherapy with carboplatin or hyerfractionated accelerated irradiation with carboplatin. Results will be forthcoming.

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Combined postoperative radiotherapy and weekly cisplatin infusion for locally advanced squamous cell carcinoma of the head and neck: Preliminary report of a randomized trial

Cited by 116 publications

References 13 publications

Postoperative Irradiation for Squamous Cell Carcinoma ofHead and Neck: Retrospective Comparison of Accelerated Radiochemotherapy and Standard Radiotherapy

Postoperative Irradiation for Squamous Cell Carcinoma ofHead and Neck: Retrospective Comparison of Accelerated Radiochemotherapy and Standard Radiotherapy

An Investigation into the Use of Pilocarpine as a Sialagogue in Patients With Radiation Induced Xerostomia

Combined Radiochemotherapy with Carboplatin in the Treatment of Advanced Head and Neck Carcinomas

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