Ramón Galiana

Hospital Universitari de Bellvitge, l'Hospitalet de Llobregat, Catalonia, Spain

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Publications (7)12.07 Total impact

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    ABSTRACT: Concurrent chemotherapy and radiotherapy is recommended for the treatment of locally advanced unresectable head and neck (H&N) cancer. The primary purpose of the Phase I part of the study was to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and recommended dose (RD) of docetaxel with hyperfractionation radiotherapy. The primary objective of the Phase II part was to determine the response rate to the RD of treatment and, secondarily, to assess the toxicity of the schedule, time to progression, duration of response and overall survival (OS). Patients (n=9 in Phase I; n=19 in Phase II) had unresectable H&N cancer. The starting docetaxel dose was 20 mg/m(2) plus hyperfractionated radiotherapy. Ramping of docetaxel was 5 mg/m(2) if MTD was not reached. MTD of docetaxel was 20 mg/m(2). Limiting toxicities were grade 4 pneumonia and grade 4 mucositis. The RD was 15 mg/m(2). Phase II initial response was 76% (CR=18%; PR=9%); updated response was 89% (CR=59%; PR=29%). The median progression-free survival was 7.8 months (95%CI: 0-22.3) and the median OS was 15.1 months (95%CI: 0-35.9). Grade 3-4 toxicities included mucositis (91%), pneumonia (27%) and fatigue (27%). There were 5 toxic deaths (2 from intestinal perforation, 3 from pneumonia). Weekly docetaxel+hyperfractionation radiotherapy is active but with high toxicity rates and, hence, this treatment regimen would be difficult to justify.
    Clinical and Translational Oncology 04/2011; 13(4):254-60. · 1.28 Impact Factor
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    ABSTRACT: Standard treatment with concomitant chemotherapy (CT) and radiotherapy (RT) for nasopharyngeal cancer has shown rates of locoregional control of 80% and has improved the rate of 5-year survival to 67% to 84%. Hyperfractionated radiotherapy (HFRT) may increase locoregional control of tumors of the head and neck, but the addition of concomitant CT involves an unacceptable level of toxicity. Adding induction CT may control distant metastasis. Here we compare the results of our protocol with induction CT followed by HFRT alone with the results obtained with concomitant treatments. Between October 1994 and May 2002, 46 patients with nasopharyngeal carcinoma were treated with HFRT. The patients with N+ or T4 lesions also received cisplatin-based induction CT (55%). The patients received a mean of 3 CT cycles (range, 2 to 5). At 5 years, the rate of progression-free survival was 66% (range, 51.3% to 82.1%), and the global survival rate was 75.7% (range, 61.9% to 89.5%). The use of HFRT in association with induction CT in patients with the greatest risk of metastasis may be as effective as concomitant CT-RT for treatment of nasopharyngeal cancer. Efforts should now concentrate on minimizing the acute and chronic toxicities.
    The Annals of otology, rhinology, and laryngology 07/2009; 118(6):442-8. · 1.21 Impact Factor
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    ABSTRACT: The contribution of induction chemotherapy (CT) followed by hyperfractionated radiotherapy (hfRT) in unresectable squamous head and neck cancer has been evaluated in a single institution as an assistencial protocol. From March 1994 to June 2000 all consecutive patients with unresectable disease were treated with four courses of platin plus fluorouracil based CT followed by hfRT. Tumor resectability and response was assessed by a multidisciplinary committee. Ninety-nine patients (pts) were treated. All of them had stage IV-M0 disease: 67 T4, 88 N2-N3. Tumor location: 62 oropharynx, 22 hypopharynx, eight oral cavity and seven larynx. Tumor response at the end of treatment: 61 patients complete response, 17 partial response, two stable disease, 10 progressive disease and nine unevaluated. With a median follow-up of 70 months the 5-year loco-regional control and overall survival was 30.3% (95% CI: 21.9-38.6) and 21.6% (95% CI: 13.4-29.8), respectively. Loco-regional control and overall survival is significantly influenced by prior response to induction CT. Main grade 3-4 toxicity related to CT was stomatitis, but there were five patients with an ischemic event. Grade 3-4 acute toxicity related to hfRT: 47 stomatitis, 20 epithelitis. Chronic toxicity related to hfRT: six emergency tracheotomies due to laryngeal edema, five pneumonia and one mucous/soft-tissue necrosis. There were eight toxic related deaths. Induction CT followed by hfRT might increase the overall survival rate in unresectable disease. HfRT resulted in a high rate of acute toxicity and its use would not be warranted in those patients with no response to induction CT who had a low probability of long-term control.
    Cancer/Radiothérapie 04/2008; 12(2):88-95. · 1.48 Impact Factor
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    ABSTRACT: Radiotherapy with concurrent cisplatin is the standard alternative to total laryngectomy for patients with locally advanced laryngeal cancer. The value of induction chemotherapy in larynx-preservation therapies remains unknown. Hyperfractionation radiotherapy might improve disease-free survival. From August 1993 to August 2004, 71 patients with T3N0-1 larynx tumors and eligible for total laryngectomy received induction chemotherapy with three cycles of cisplatin plus fluorouracil. Clinical tumor response was assessed by indirect laryngoscopy and computed tomography scan. Patients with complete response received hyperfractionation radiotherapy, whereas those without complete response were proposed for total laryngectomy. A total of 71 consecutive patients were included. Thirty-three patients achieved complete response to induction chemotherapy (46.5%), four of them presented a tumor relapse, and all underwent salvage surgery. Seventy-six percent of surviving patients preserved a functional larynx. Despite not achieving complete response, 15 patients refused total laryngectomy and received hyperfractionation radiotherapy. Seven patients presented a tumor relapse and salvage surgery was performed in three of them. Fifty percent of surviving patients preserved a functional larynx. Twenty-two patients without complete response underwent total laryngectomy; three of them presented a tumor relapse but none could be rescued. With a median follow up of 68 months, 5 five-year overall survival, 5-year disease-free survival, and 5-year larynx function preservation survival rates were 68% (confidence interval [CI], 57-80), 75% (CI, 64-87), and 42% (CI, 29-54), respectively. No differences in overall survival were observed between groups. Five-year disease-free survival of patients without complete response who received hyperfractionation radiotherapy was significantly lower than that of the other two groups (P < .02). Ten patients with larynx preservation and no tumor relapse had chronic toxicity that caused the loss of larynx function: seven patients required permanent tracheotomy, two died from pneumonia, and one patient died as a result of a laryngeal necrosis. Patients with complete response to induction chemotherapy in laryngeal carcinoma have a high probability of cure after hyperfractionation radiotherapy. However, hyperfractionation radiotherapy induces a high degree of toxicity that reduces the laryngeal function preservation rate and may jeopardize overall survival.
    The Laryngoscope 10/2006; 116(9):1651-6. · 1.98 Impact Factor
  • Ejc Supplements - EJC SUPPL. 01/2003; 1(5).
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    ABSTRACT: The purpose of this work is to evaluate the contribution of hyperfractionated radiotherapy (RT) in head and neck cancer by sub-localisation. From 1992 to 1999, 318 patients with squamous head and neck tumours treated by hyperfraction RT were analysed according to their sub-localisation and stage. Fractions used were 1.2 Gy twice-a-day with a curative intent on all patients, to a total mean dose of 79.14 Gy. Treatment protocols by localisation were: larynx: 55 patients with T2N0 and T1-2N1 tumours treated with only RT and 27 patients with T3N0-1 in complete remission after three cycles of induction chemotherapy (ICT); hypopharynx: 29 patients with T2-4N0-2b resectable tumors in response to three cycles of ICT; oropharynx: 48 patients with T2-3N0-1 and T1N1 tumours treated with only RT; 34 patients with nasopharynx tumours treated with RT and three cycles of ICT if T4 or >N1; finally, 125 patients with non-surgical tumours of any localisation treated with four cycles of induction CT and RT. LARYNX: Actuarial local control (LC), disease-free survival (DFS) and overall survival (OS) at 5 years were 78, 73 and 48%, respectively, in T2 tumours and 75, 72 and 60% in stage III disease. HYPOPHARYNX: Actuarial LC, DFS and OS at 4 years were 44, 39 and 35%, respectively. OROPHARYNX: Actuarial LC, DFS and OS at 5 years were 52, 44 and 31%, respectively. NASOPHARYNX: Actuarial LC, DFS and OS at 5 years were 78, 72 and 78%, respectively. NON-SURGICAL TUMORS: Actuarial LC, DFS and OS at 5 years were 39, 33 and 19%, respectively. A total of 47 patients (14.8%) of the overall group had a second tumour, 72% of them tobacco-related. Only patients with nasopharynx tumours had a low incidence of second tumours. Twice-a-day external RT can be effectively managed in patients with head and neck cancer. Second neoplasm and intercurrent diseases become an important problem in low and medium stages whereas disease recurrences is the main problem in advanced stages. Results by localisation permit to obtain conclusions about their indications in each one.
    Radiotherapy and Oncology 08/2002; 64(1):19-27. · 4.52 Impact Factor
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    ABSTRACT: The treatment of squamous cell carcinoma of the mouth and oropharynx continues to change. In this primary report, we compared the results obtained by combined surgery and radiation therapy, or either modality alone. Other methods such as brachytherapy, or hyperfractionated radiotherapy, were not included in our protocols. A statistical analysis of the 3- and 5-year survival rates in relation to location and size of the primary tumour, stage at initial presentation, treatment modality and recurrence, was carried out in 88 patients with squamous cell carcinoma of the oral cavity or oropharynx. The overall survival rate was 73.8% at 3 years and 66.3% at 5 years. Size of tumour and stage at presentation were significant when P value was adjusted by site. Survival was significantly associated with type of treatment (combined approach obtained superior results), location of primary tumour, and recurrence. The type of neck dissection did not show any effect. Therapeutic modality used, stage, and location of primary tumour significantly influenced survival. A more selective combined initial treatment according to site and stage (distribution) is recommended.
    Journal of Cranio-Maxillofacial Surgery 03/2000; 28(1):49-55. · 1.61 Impact Factor