Larynx Preservation in Pyriform Sinus Cancer: Preliminary Results of a European Organization for Research and Treatment of Cancer Phase III Trial

Lefebvre, Jean‐Louis; Chevalier, Dominique; Luboinski, B.; Kirkpatrick, A.; Collette, Laurence; Sahmoud, Tarek

doi:10.1093/jnci/88.13.890

Cited by 1,224 publications

(818 citation statements)

References 11 publications

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“…Randomized Phase III data have confirmed that induction platinum-based, multiagent chemotherapy given before radiotherapy alone can provide outcomes equivalent to larynx-sacrificing surgery for locally advanced hypopharyngeal and laryngeal disease. 16,17 Until recently, induction chemotherapy before local therapy for other head and neck subsites remained out of favor due to the lack of consistent supportive Phase III evidence for a significant survival benefit. 18 -20 More current Phase III data from Europe using cisplatin and 5-FU suggest a survival benefit to induction therapy, 21 and recent Phase II results for taxanebased induction chemotherapy have further raised interest in this approach.…”

Section: Discussionmentioning

confidence: 99%

Phase I and initial phase II results from a trial investigating weekly docetaxel and carboplatin given neoadjuvantly and then concurrently with concomitant boost radiotherapy for locally advanced squamous cell carcinoma of the head and neck

Schwartz

Montgomery

Yueh

et al. 2005

Cancer

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BACKGROUNDThe current Phase I/II study assessed induction docetaxel/carboplatin given weekly for 4 weeks, followed by weekly docetaxel/carboplatin and concomitant boost radiotherapy (CB‐XRT) for locally advanced head and neck squamous cell carcinoma.METHODSTwenty patients with Stage III or IV (M0) disease of the oropharynx, supraglottic larynx, or hypopharynx were enrolled. Patients initially received docetaxel 20 mg/m2 and carboplatin area under the curve (AUC) 2 weekly × 4. Patients with stable (SD) or responding disease subsequently received dose‐escalated docetaxel (10–20 mg/m2 in sequential patient cohorts) and carboplatin AUC 1 weekly × 5 with CB‐XRT (1.8 gray [Gy] every day × 15 days, followed by 1.8/1.5 Gy twice per day × 13 days).RESULTSAll patients were evaluable, and 15 patients (5 patients with Stage III disease, 10 patients with Stage IV disease) completed all planned therapy. The target docetaxel dose level of 20 mg/m2 weekly with radiotherapy was achieved with no dose‐limiting toxicities. The most frequent maximum toxicities during chemoradiotherapy were Grade 3 mucositis, dysphagia, and/or pain. Primary site responses after induction included 4 patients with partial responses, 11 patients with SD, and 5 patients with disease progression. Fifteen patients (75%) continued to receive chemoradiotherapy, with 14 patients attaining a complete response (CR). Overall, a clinicopathologic neck CR after chemoradiotherapy was achieved in 9 of 10 patients. One patient had persistent primary disease and underwent salvage surgery, whereas another died of unrelated causes before neck assessment. Thirteen patients remain free of any disease event, with a median follow‐up of 15 months (range, 3–29 months).CONCLUSIONSThis regimen was feasible, safe, and particularly well tolerated. Early Phase II outcomes revealed promising activity in patients completing all treatment. Initial induction response results suggested that further investigation of this regimen with more aggressive induction therapy is warranted. Cancer 2005. © 2005 American Cancer Society.

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Section: Discussionmentioning

confidence: 99%

Phase I and initial phase II results from a trial investigating weekly docetaxel and carboplatin given neoadjuvantly and then concurrently with concomitant boost radiotherapy for locally advanced squamous cell carcinoma of the head and neck

Schwartz

Montgomery

Yueh

et al. 2005

Cancer

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“…However, unlike advanced laryngeal cancers, the question of organ preservation [16,20] has not been subjected to rigorous evaluation in hypopharyngeal cancers, precluding firm conclusions. The most widely discussed organ preservation trial for hypopharyngeal cancers, the European Organization for Research and Treatment of Cancer (EORTC) 24891 [21] randomized patients with advanced cancers of the hypopharynx and lateral epilarynx to induction chemotherapy followed by radiotherapy (surgery for non-responders) or surgery followed by post-operative adjuvant radiotherapy. The trial however closed prematurely after accruing 202 patients due to difficulty in getting consent for surgery.…”

Section: Organ Preservation and Hypopharyngeal Cancersmentioning

confidence: 99%

Squamous cell carcinoma of the hypopharynx: Single-institution outcome analysis of a large cohort of patients treated with primary non-surgical approaches

et al. 2009

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“…In contrast, the role of induction chemotherapy is not yet clear. Although not the standard of care, induction chemotherapy is used in clinical practice and is thought to be beneficial for reducing the rate of distant metastases (Paccagnella et al, 1994;Lefebvre et al, 1996), increasing organ preservation (Group, 1991;Lefebvre et al, 1996) and survival rates (Paccagnella et al, 1994;Zorat et al, 2004). Combining induction and concomitant chemotherapy with radiation, that is, in a sequential treatment approach, has the potential for improving disease outcomes.…”

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confidence: 99%

Sequential induction chemotherapy followed by radical chemo-radiation in the treatment of locoregionally advanced head-and-neck cancer

et al. 2008

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We describe a retrospective series of patients with advanced head-and-neck cancer who were treated with induction chemotherapy followed by radical chemo-radiation. Patients treated with two cycles of induction chemotherapy followed by definitive chemoradiation for squamous cell carcinoma of the head-and-neck region, from 2001 -2006 at the Royal Marsden Hospital, formed the basis of this study. Cisplatin (75 mg m À2 ) on day 1 and 5-FU (1000 mg m À2 ) day 1 -4 was the standard regimen used for induction treatment. Cisplatin (100 mg m À2 ) on day 1 and day 29 was used for concomitant treatment. The radiation was delivered using conformal technique. Tissues containing macroscopic and microscopic disease were treated to doses of 65 Gray (Gy) in 30 fractions and 50 Gy in 25 fractions, respectively. Data on patterns of relapse and acute toxicity (NCICTCv.3.0) were collected. A total of 129 patients were included, median age was 58 (range: 27 -78). The site of tumour was: oropharynx 70 (54%), larynx 30 (23%), hypopharynx 24 (19%) and other 5 (4%). The median follow-up was 19 months (range: 4 -58). Local control, disease-specific survival and overall survival at 2 years were 71%, 68% and 63%, respectively. The distant recurrence rate at 2 years was 9%. Ten patients required dose reduction during induction chemotherapy due to toxicity. The dose of 5-FU was reduced in six patients and that of cisplatin in four patients. The incidence of grade 3/4 toxicity was: neutropenia 5%, thrombocytopenia 1%, nausea and vomiting 3%. One cycle of concurrent cisplatin was omitted in 23 patients due to toxicity. Full-dose radiotherapy was administered to 98% of patients. The incidence of grade 3/4 toxicity was: skin 20%, dysphagia 65%, mucositis 60%, neutropenia 3%, anaemia 1%, nausea and vomiting 4%, nephrotoxicity 1%. Induction chemotherapy followed by radical chemo-radiation is a safe and tolerable regimen in the treatment of advanced head-and-neck cancer. Distant recurrence rates are lower with equivalent local control and survival compared to chemo-radiation alone (historical controls).

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Larynx Preservation in Pyriform Sinus Cancer: Preliminary Results of a European Organization for Research and Treatment of Cancer Phase III Trial

Cited by 1,224 publications

References 11 publications

Phase I and initial phase II results from a trial investigating weekly docetaxel and carboplatin given neoadjuvantly and then concurrently with concomitant boost radiotherapy for locally advanced squamous cell carcinoma of the head and neck

Phase I and initial phase II results from a trial investigating weekly docetaxel and carboplatin given neoadjuvantly and then concurrently with concomitant boost radiotherapy for locally advanced squamous cell carcinoma of the head and neck

Squamous cell carcinoma of the hypopharynx: Single-institution outcome analysis of a large cohort of patients treated with primary non-surgical approaches

Sequential induction chemotherapy followed by radical chemo-radiation in the treatment of locoregionally advanced head-and-neck cancer

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