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.

Transoral robotic surgery for squamous cell carcinoma of the oropharynx in a primarily human papillomavirus-negative patient population.

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.

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.

[Dose intensity received in breast cancer treatment with chemotherapy]. / Intensidad de dosis recibida en el tratamiento quimioterápico del cáncer de mama.

OBJECTIVE: To know relative dose intensity (RDI) in patients with breast cancer treated with chemotherapy. To determine the number of patients where RDI was < 85% of that programmed and the possible cause. METHOD: Retrospective study, four-month selection period. The following were recorded: age, body surface, protocol applied, intention of treatment, frequency of administration of cycles, number of cytostatic treatments previously received and filgrastim administration. The average RDI per patient and protocol was calculated. RESULTS: 110 patients were analysed, the average age of them being 55.4 years (interval: 31-84), average body surface 1.7 m2 (1.3-2.4). Overall average RDI was 91.0% (SD 10.7). 93.8% (10.6), 95.8% (6.3) and 81.9% (18.5) in neoadjuvant, adjuvant and palliative treatments, respectively. 20% of the patients did not reach a RDI = 85% of that programmed, average RDI 69.5% (3.29). A delay in the administration of chemotherapy equal or greater than seven days occurred in 45.4% of the cases, average RDI 80.7% (16.0). In the episodes where the dose was reduced because of toxicity, the RDI was 75.6% (13.6). Significant inverse ratios were obtained with age (p = 0.02) and line of treatment (p = 0.03) with the RDI. In 36.8%, dose reduction was caused by neutropenia; 52.9% received filgrastim. CONCLUSIONS: Most patients received the appropriate RDI. Age, previous treatments and intention of treatment were the variables with the greatest impact on the dose received. The delay in administering the cycle was the most frequent act minimising the toxicity and which least affected the treatment.