Sequential chemotherapy regimen of induction with panitumumab and paclitaxel followed by radiotherapy and panitumumab in patients with locally advanced head and neck cancer unfit for platinum derivatives. The phase II, PANTERA/TTCC-2010-06 study.

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.

Long-term outcomes of induction chemotherapy followed by chemoradiotherapy vs chemoradiotherapy alone as treatment of unresectable head and neck cancer: follow-up of the Spanish Head and Neck Cancer Group (TTCC) 2503 Trial.

BACKGROUND: Our previous phase-3 study (TTCC 2503) failed to show overall survival advantage of 2 induction chemotherapy (IC) regimens followed by standard concurrent chemoradiotherapy (CRT) over CRT alone in patients with unresectable locally advanced head and neck squamous-cell carcinoma (LAHNSCC). This study described the long-term survival of those patients. MATERIALS AND METHODS: Long-term follow-up study of patients with untreated LAHNSCC assigned to IC (three cycles), with either docetaxel, cisplatin and 5-fluorouracil (TPF arm) or cisplatin and 5-fluorouracil (PF arm), followed by CRT, or CRT alone, included in the previous TTCC 2503 trial. RESULTS: In the intention-to-treat population (n = 439), the median OS times were 25.4 (95% CI, 16.8-34.4), 26.2 (95% CI, 18.2-36.6) and 25.4 months (95% CI, 17.4-36.0) in the TPF-CRT, PF-CRT and CRT arms, respectively (log-rank p = 0.51). In the per-protocol population (n = 355), patients with larynx-hypopharynx primary tumors treated with IC (TPF or PF) followed by CRT had a longer median PFS than those who received CRT alone. Moreover, patients with ECOG 0 treated with IC (TPF or PF) followed by CRT had a better TTF than those with CRT alone. There were no statistically significant differences in terms of OS, PFS or TTF, according to the tumor load or affected nodes. CONCLUSION: After a long follow-up, the TTCC 2503 trial failed to show the benefit of IC-CRT in unresectable LAHNSCC regarding the primary end point. However, fit patients with ECOG 0 and primary larynx-hypopharyngeal tumors may benefit from the use of IC if administered by an experienced team. ClinicalTrials.gov identifier NCT00261703.

SEOM clinical guidelines for the treatment of head and neck cancer (2017).

Head and neck cancer (HNC) is defined as malignant tumours located in the upper aerodigestive tract and represents 5% of oncologic cases in adults in Spain. More than 90% of these tumours have squamous histology. In an effort to incorporate evidence obtained since 2013 publication, Spanish Society of Medical Oncology (SEOM) presents an update of HNC diagnosis and treatment guideline. The eighth edition of TNM classification, published in January 2017, introduces important changes for p16-positive oropharyngeal tumours, for lip and oral cavity cancer and for N3 category. In addition, there are new data about induction chemotherapy and the role of immunotherapy in HNC.

Validation of the International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) prognostic model for first-line pazopanib in metastatic renal carcinoma: the Spanish Oncologic Genitourinary Group (SOGUG) SPAZO study.

BACKGROUND: Patients with metastatic renal carcinoma (mRCC) treated with first-line pazopanib were not included in the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic model. SPAZO (NCT02282579) was a nation-wide retrospective observational study designed to assess the effectiveness and validate the IMDC prognostic model in patients treated with first-line pazopanib in clinical practice. PATIENTS AND METHODS: Data of 278 patients, treated with first-line pazopanib for mRCC in 34 centres in Spain, were locally recorded and externally validated. Mean age was 66 years, there were 68.3% male, 93.5% clear-cell type, 74.8% nephrectomized, and 81.3% had ECOG 0-1. Metastatic sites were: lung 70.9%, lymph node 43.9%, bone 26.3%, soft tissue/skin 20.1%, liver 15.1%, CNS 7.2%, adrenal gland 6.5%, pleura/peritoneum 5.8%, pancreas 5%, and kidney 2.2%. After median follow-up of 23 months, 76.4% had discontinued pazopanib (57.2% due to progression), 47.9% had received second-line targeted therapy, and 48.9% had died. RESULTS: According to IMDC prognostic model, 19.4% had favourable risk (FR), 57.2% intermediate risk (IR), and 23.4% poor risk (PR). No unexpected toxicities were recorded. Response rate was 30.3% (FR: 44%, IR: 30% PR: 17.3%). Median progression-free survival (whole population) was 11 months (32 in FR, 11 in IR, 4 in PR). Median and 2-year overall survival (whole population) were 22 months and 48.1%, respectively (FR: not reached and 81.6%, IR: 22 and 48.7%, PR: 7 and 18.8%). These estimations and their 95% confidence intervals are fully consistent with the outcomes predicted by the IMDC prognostic model. CONCLUSION: Our results validate the IMDC model for first-line pazopanib in mRCC and confirm the effectiveness and safety of this treatment.

Skull base chondrosarcoma: a case treated by the CyberKnife system

Skull base chondrosarcomas represent 2% of all chondrosarcomas. They usually have a low grade of malignity and a complete resection may be curative. However, often they are considered irresectable because of the difficult approach and another kind of treatment is needed. We present a 54-year-old male case who, after weeks suffering from diplopia, was diagnosed with skull base chondrosarcoma and treated with the CyberKnife system. A review of radiosurgery techniques for skull base neoplasms is carried out (AU)

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El uso de fentanilo transdérmico por una unidad de atención domiciliaria en pacientes oncológicos en el final de la vida / Use of transdermic fentanyl by a department of home medical care of terminal oncologic patients

• Propósito: Se ha realizado un estudio observacional y retrospectivo para evaluar el modo de utilizacióny los efectos secundarios de fentanilo transdérmico (FTTS) en pacientes oncológicos en situación terminal.• Material y métodos: Se han evaluado estadísticamente pacientes incluidos en un programa de AtenciónDomiciliaria que recibieron tratamiento con FTTS.• Resultados: 112 pacientes (p) recibieron tratamiento con FTTS. Mediana de edad de 71.5 años (29-88).102p presentaban dolor y 10 disnea. Tipo de dolor: visceral 55% p, óseo 25% p, neuropático 12.5%, muscular5% p y otro 2.5% p. EVA inicial: media 5.9. La analgesia previa a la utilización de fentanilo fue: 31% p AINES,32.2% p tramadol, 5.6% p codeína y 31% p morfina. La dosis mediana inicial de fentanilo fue 50mgr/hora(25-300). La dosis mediana final fue 75 mgr/hora (25-400). EVA final media: 3,3. La mediana de la duracióndel tratamiento fue de 44 días (1-372). 35 p (31%) presentaron náuseas G2-3, somnolencia 5 p, agitacióny/o delirio 13 p. 81 p (72%) precisaron laxantes. En 10 p fue necesario rotar a otro opioide: 4 p por toxicidad y6 p por mal control del dolor.• Conclusiones: El FTTS es un analgésico bien tolerado en pacientes terminales y proporciona una analgesiaadecuada (91%), a un bajo coste en cuanto a yatrogenia intolerable (4%), tanto con paso previo conopioides como directamente desde primer escalón analgésico OMS

• Purpose: An observational and retrospective study was performed in order to evaluate the activity andtoxicity of transdermal fentanyl in patients with advanced cancer.• Material and methods: 112 patients treated by a home palliative care unit were studied. Thecharacteristics of patients, analgesic treatments, and opioid rotation were analysed from the beginning offentanyl administration to the death.• Results: The mean age of the patients (p) was 71.5 years (range, 29-88). The indication for opioidadministration was pain in 102 and dyspnea in 10 patients. The type of pain was visceral in 56 p (55%), bonyin 25 p (25%), neuropatic in 13 p (12.8%), muscular in 5 p (5%), and others in 3 p (2.1%). The baseline meanvalue of the pain analogical visual scale (AVS) was 5.9. The analgesics administered before fentanyl was givenwere tramadol (32.2%), NSAIDs (31%), morphine (31%) and codeine (5.6%). The median initial dose offentanyl was 50 µg (range, 25-300). The final mean dose at the time of death was 75 µg (25-400). The finalmean AVS was 3.3. The median treatment duration was 44 days (range, 1 to 372). It caused G2-3 nausea in 35p (31%), somnolence in 13 p, and agitation in 5 p; 81 patients received laxatives. Opioid rotation withmorphine was necessary in 10 p because of toxicity, and in 6 p because uncontrolled pain.• Conclusions: Transdermal fentanyl is a well tolerated analgesic in patients with advanced cancer,providing a good analgesia in up to 91% of the patients previously treated with opioids, as well as of thepatients proceeding directly from the first or second step of the WHO ladder