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1.
Clin. transl. oncol. (Print) ; 23(8): 1666-1677, ago. 2021.
Article in English | IBECS | ID: ibc-222165

ABSTRACT

Background Sequential treatment of Panitumumab (Pb) plus Paclitaxel (Px) as induction treatment (IT) followed by concurrent bioradiotherapy (Bio–RT) with Pb may be an alternative for locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) in patients ineligible for high-dose cisplatin therapy. Methods Phase II, single-arm, multicentre study, with two-stage design, in patients ≥ 18 years with stage III–IVa–b LA-SCCHN unfit for platinum. Patients received Px + Pb (9 weeks) as IT followed by Bio–RT + Pb. Primary endpoint: overall response rate (ORR) after IT, defined as: more than 70% of patients achieving complete response (CR) or partial response (PR) to IT. Secondary end-points: progression-free survival, organ preservation rate, safety profile. Results Study ended prematurely (51 patients) due to slow recruitment. ORR: 66.7% (95% CI: 53.7–79.6), 8 (15.7%) CR and 26 (51.0%) PR. 39 patients (76%) completed radiotherapy (RT). Pb and/or Px-related adverse events (AEs) grade 3–4: 56.9% during IT and 63.4% during the concomitant phase, of which most common were skin toxicity (33.3%). Five deaths occurred during treatment, two of them (3.9%) were Pb and/or Px-related. Conclusions Although underpowered, ORR was higher than the pre-specified boundary for considering the treatment active. Although Px + Pb as IT provides some benefit, the safety profile is worse than expected. To consider Pb + Px as IT as an alternative for platinum-unsuitable LA-SCCHN, further research/investigation would be needed (AU)


Subject(s)
Humans , Male , Female , Middle Aged , Aged , Aged, 80 and over , Squamous Cell Carcinoma of Head and Neck/radiotherapy , Squamous Cell Carcinoma of Head and Neck/drug therapy , Panitumumab/administration & dosage , Paclitaxel/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Head and Neck Neoplasms/drug therapy , Head and Neck Neoplasms/radiotherapy , Squamous Cell Carcinoma of Head and Neck/mortality , Squamous Cell Carcinoma of Head and Neck/pathology , Progression-Free Survival , Spain , Head and Neck Neoplasms/mortality , Head and Neck Neoplasms/pathology
2.
Clin Transl Oncol ; 23(8): 1666-1677, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33876416

ABSTRACT

BACKGROUND: Sequential treatment of Panitumumab (Pb) plus Paclitaxel (Px) as induction treatment (IT) followed by concurrent bioradiotherapy (Bio-RT) with Pb may be an alternative for locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) in patients ineligible for high-dose cisplatin therapy. METHODS: Phase II, single-arm, multicentre study, with two-stage design, in patients ≥ 18 years with stage III-IVa-b LA-SCCHN unfit for platinum. Patients received Px + Pb (9 weeks) as IT followed by Bio-RT + Pb. Primary endpoint: overall response rate (ORR) after IT, defined as: more than 70% of patients achieving complete response (CR) or partial response (PR) to IT. Secondary end-points: progression-free survival, organ preservation rate, safety profile. RESULTS: Study ended prematurely (51 patients) due to slow recruitment. ORR: 66.7% (95% CI: 53.7-79.6), 8 (15.7%) CR and 26 (51.0%) PR. 39 patients (76%) completed radiotherapy (RT). Pb and/or Px-related adverse events (AEs) grade 3-4: 56.9% during IT and 63.4% during the concomitant phase, of which most common were skin toxicity (33.3%). Five deaths occurred during treatment, two of them (3.9%) were Pb and/or Px-related. CONCLUSIONS: Although underpowered, ORR was higher than the pre-specified boundary for considering the treatment active. Although Px + Pb as IT provides some benefit, the safety profile is worse than expected. To consider Pb + Px as IT as an alternative for platinum-unsuitable LA-SCCHN, further research/investigation would be needed.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Head and Neck Neoplasms/drug therapy , Head and Neck Neoplasms/radiotherapy , Paclitaxel/therapeutic use , Panitumumab/therapeutic use , Squamous Cell Carcinoma of Head and Neck/drug therapy , Squamous Cell Carcinoma of Head and Neck/radiotherapy , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Cause of Death , Early Termination of Clinical Trials , Female , Head and Neck Neoplasms/mortality , Head and Neck Neoplasms/pathology , Humans , Induction Chemotherapy/methods , Male , Middle Aged , Organ Sparing Treatments , Paclitaxel/adverse effects , Panitumumab/adverse effects , Progression-Free Survival , Spain , Squamous Cell Carcinoma of Head and Neck/mortality , Squamous Cell Carcinoma of Head and Neck/pathology
3.
Clin Transl Oncol ; 22(8): 1303-1311, 2020 Aug.
Article in English | MEDLINE | ID: mdl-31858433

ABSTRACT

PURPOSE: Transoral robotic surgery (TORS) is one of the main treatment options for non-locally advanced primary oropharyngeal cancer in the United States. However, its use is more limited in countries with a low incidence of human papillomavirus (HPV), such as Spain, in patients with advanced disease, and as salvage surgery. To shed light on the use and potential benefit of TORS in Spanish patients, we analyzed the functional and oncologic outcomes of TORS as both primary and salvage surgery in a primarily HPV-negative population which is representative of oropharyngeal squamous cell carcinoma (OPSCC) patients in Spain. MATERIAL AND METHODS: This is a retrospective analysis of prospectively collected data on OPSCC patients treated with TORS at our center between February 2017 and February 2019. RESULTS: Fifty-four OPSCC patients were included; 79.6% were males and 80.5% were HPV negative. Median age was 62 years. Primary surgery was performed on 73.7% (48.1% stage I-II; 51.9% stage III-IV) and salvage surgery on 25.9% of patients. Positive margin rates were 4.3% for T1-2 and 25.8% for T3-4. None of the stage I-II patients and 27.7% of stage III-IV patients required adjuvant treatment. Reconstructive surgery was performed in 19.2% of all patients. Normal swallowing was achieved in 92.7% of patients at 6 months after surgery. 1- and 2-year survival rates for all patients were 94.5% and 89%, respectively. The overall complication rate was 16.1%. Bleeding occurred in 11.5% of patients. Longer hospitalization time was associated with surgical complications (P = 0.03) and reconstructive surgery (P = 0.03) but not with salvage surgery. CONCLUSION: TORS is a safe and effective treatment for HPV-negative T1-2 OPSCC patients. The positive margin rate was worse in T3-4 patients, indicating the need for careful patient selection in this subgroup.


Subject(s)
Oropharyngeal Neoplasms/surgery , Robotic Surgical Procedures/methods , Squamous Cell Carcinoma of Head and Neck/surgery , Adult , Aged , Aged, 80 and over , Alphapapillomavirus , Deglutition , Female , Humans , Male , Middle Aged , Mouth , Negative Results , Oropharyngeal Neoplasms/mortality , Retrospective Studies , Salvage Therapy/statistics & numerical data , Squamous Cell Carcinoma of Head and Neck/mortality
4.
Clin. transl. oncol. (Print) ; 12(11): 742-748, nov. 2010. tab, ilus
Article in English | IBECS | ID: ibc-124368

ABSTRACT

Head and neck cancer constitutes the fifth highest cause of cancer in Spain. It is a neoplasm with a high possibility of cure if it is diagnosed in early stages, but unfortunately two thirds of the patients are diagnosed at an advanced loco-regional stage (stage III and IV, without metastasis). The multidisciplinary team, bringing together all professionals who specialize in the diagnosis and treatment of these tumors make the decision to establish the best sequence of individualized diagnosis, staging and treatment for each patient. This guide gives recommendations for diagnosis, staging and treatment for squamous cell carcinoma of the head and neck. In order to simplify the amount of information about any subsite of the head and neck area, the treatment recommendations are summarized as local disease, locally advance resectable and unresectable stages, function-preserving laryngeal treatment and recurrent and metastatic disease (AU)


Subject(s)
Humans , Male , Female , Carcinoma, Squamous Cell/therapy , Head and Neck Neoplasms/therapy , Carcinoma, Squamous Cell/epidemiology , Practice Guidelines as Topic , Algorithms , Medical Oncology/methods , Medical Oncology/organization & administration , Medical Oncology/trends , Societies, Medical/organization & administration , Societies, Medical/standards , Societies, Medical , Spain/epidemiology
5.
Clin. transl. oncol. (Print) ; 12(11): 749-752, nov. 2010. tab, ilus
Article in English | IBECS | ID: ibc-124369

ABSTRACT

Nasopharyngeal carcinoma is an unusual tumour in Spain. It has differences in epidemiology, histology, clinical behaviour, treatment and prognosis from those of other head and neck neoplasms, which justifies separate analysis. It is a neoplasm with a high possibility of cure with a combined treatment if even it is diagnosed in an advanced locoregional stage (stage III or IV, without metastasis). The multidisciplinary team, bringing together all professionals who specialize in the diagnosis and treatment of these tumors make the decision to establish the best sequence of individualized diagnosis, staging and treatment for each patient. This guide gives recommendations for diagnosis, staging and treatment for nasopharyngeal carcinoma. The treatment recommendations are summarized as local disease, locally advance and recurrent and metastatic disease (AU)


Subject(s)
Humans , Male , Female , Carcinoma/epidemiology , Carcinoma/therapy , Nasopharyngeal Neoplasms/epidemiology , Nasopharyngeal Neoplasms/therapy , Practice Guidelines as Topic , Algorithms , Medical Oncology/methods , Medical Oncology/organization & administration , Medical Oncology/trends , Societies, Medical/organization & administration , Societies, Medical/standards , Societies, Medical , Spain/epidemiology
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