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 (AU)

Population-based risk assessment of second primary cancers following a first head and neck cancer: patterns of association and difficulties of its analysis

Purpose The diagnosis of a second primary cancer (SPC) is a major concern in the follow-up of survivors of a primary head and neck cancer (HNC), but the anatomic subsites in the head and neck area are close, making it difficult to distinguish a SPC of a recurrence and therefore register it correctly. Methods We performed a retrospective cohort study using data from two population-based cancer registries in Catalonia, Spain: the Tarragona Cancer Registry and the Girona Cancer Registry. All patients diagnosed with HNC during the period 1994–2013 were registered and followed-up to collect cases of SPC. We analysed the standardized incidence ratio (SIR) and the excess absolute risk (EAR) to determine the risk of second malignancies following a prior HNC. Results 923 SPC were found in a cohort of 5646 patients diagnosed of a first head and neck cancer. Men had an increased risk of a SPC with a SIR of 2.22 and an EAR of 216.76. Women also had an increased risk with a SIR of 2.02 and an EAR of 95.70. We show the risk for different tumour sites and discuss the difficulties of the analysis. Conclusion The risks of a SPC following a prior HNC in Tarragona and Girona are similar to those previously found in other similar cohorts. It would appear to be advisable to make a revision of the international rules of classification of multiple tumours, grouping the sites of head and neck area with new aetiological criteria to better determine and interpret the risks of SPC obtained in these studies (AU)

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.

Population-based risk assessment of second primary cancers following a first head and neck cancer: patterns of association and difficulties of its analysis.

PURPOSE: The diagnosis of a second primary cancer (SPC) is a major concern in the follow-up of survivors of a primary head and neck cancer (HNC), but the anatomic subsites in the head and neck area are close, making it difficult to distinguish a SPC of a recurrence and therefore register it correctly. METHODS: We performed a retrospective cohort study using data from two population-based cancer registries in Catalonia, Spain: the Tarragona Cancer Registry and the Girona Cancer Registry. All patients diagnosed with HNC during the period 1994-2013 were registered and followed-up to collect cases of SPC. We analysed the standardized incidence ratio (SIR) and the excess absolute risk (EAR) to determine the risk of second malignancies following a prior HNC. RESULTS: 923 SPC were found in a cohort of 5646 patients diagnosed of a first head and neck cancer. Men had an increased risk of a SPC with a SIR of 2.22 and an EAR of 216.76. Women also had an increased risk with a SIR of 2.02 and an EAR of 95.70. We show the risk for different tumour sites and discuss the difficulties of the analysis. CONCLUSION: The risks of a SPC following a prior HNC in Tarragona and Girona are similar to those previously found in other similar cohorts. It would appear to be advisable to make a revision of the international rules of classification of multiple tumours, grouping the sites of head and neck area with new aetiological criteria to better determine and interpret the risks of SPC obtained in these studies.

Incidence and survival of central nervous system tumors in childhood and adolescence in Girona (Spain) 1990-2013: national and international comparisons.

INTRODUCTION: Pediatric central nervous system tumors are one of the most frequent types of neoplasms in children but epidemiological data on these tumors have been sparsely reported in the medical literature. MATERIALS AND METHODS: We analyze the epidemiology of this type of tumors performing a retrospective population-based study in pediatrics and adolescent age in the population of Girona and compare them with series from Spain, Europe and worldwide. Cases were registered using the International Classification of Disease for Oncology, third edition and grouping according the International Classification of Childhood Cancer, third edition (ICCC-3). RESULTS: For all the histologies and the whole population between 0 and 19 years old, ASRw was 41.8 cases per million person-years. In children population, meaning under 14 years old, we found 104 cases with ASRw of 45.6. Males were the most affected by CNS tumors with a 1.2 sex ratio between 0 and 14 years old, and 1.1 between 0 and 19 years old. The analysis of trends in incidence did not find any statistically significant increase or decrease. Five-year observed survival was 68%, both for patients under 19 and 14 years of age. CONCLUSIONS: The incidence in our area was among the highest in Spain and worldwide, while survival was comparable to others reported.

Patterns of increased incidence and survival of cutaneous melanoma in Girona (Spain) 1994-2013: a population-based study

Introduction: We conducted a population-based study on the Girona Cancer Registry (Spain) for the period 1994-2013 to determine patterns of change in the incidence of melanoma, which is increasing in many countries, and patient survival in our geographical area. Materials and methods: Using the standard registration rules for cancer registries, we calculated crude and standardized incidence rates as well as their trends. We also analysed the observed survival, 1-year conditioned survival and relative survival at 3, 5 and 10 years. Results: Our crude incidence rate was 9.13 cases/100,000 inhabitants for invasive and 2.59 for "in situ" melanomas. A statistically significant increase in incidence was found for melanomas of less than 1 mm in Breslow index and in males. 10-year observed and relative survival rates were 64.1 and 83.1%, respectively. Conclusions: We found an increasing trend in the incidence of low-risk melanoma and a survival rate similar to that reported elsewhere in Europe

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Patterns of increased incidence and survival of cutaneous melanoma in Girona (Spain) 1994-2013: a population-based study.

INTRODUCTION: We conducted a population-based study on the Girona Cancer Registry (Spain) for the period 1994-2013 to determine patterns of change in the incidence of melanoma, which is increasing in many countries, and patient survival in our geographical area. MATERIALS AND METHODS: Using the standard registration rules for cancer registries, we calculated crude and standardized incidence rates as well as their trends. We also analysed the observed survival, 1-year conditioned survival and relative survival at 3, 5 and 10 years. RESULTS: Our crude incidence rate was 9.13 cases/100,000 inhabitants for invasive and 2.59 for "in situ" melanomas. A statistically significant increase in incidence was found for melanomas of less than 1 mm in Breslow index and in males. 10-year observed and relative survival rates were 64.1 and 83.1%, respectively. CONCLUSIONS: We found an increasing trend in the incidence of low-risk melanoma and a survival rate similar to that reported elsewhere in Europe.

Survival of 86,690 patients with thyroid cancer: A population-based study in 29 European countries from EUROCARE-5.

BACKGROUND: Incidence rates of thyroid cancer (TC) increased in several countries during the last 30 years, while mortality rates remained unchanged, raising important questions for treatment and follow-up of TC patients. This study updates population-based estimates of relative survival (RS) after TC diagnosis in Europe by sex, country, age, period and histology. METHODS: Data from 87 cancer registries in 29 countries were extracted from the EUROCARE-5 dataset. One- and 5-year RS were estimated using the cohort approach for 86,690 adult TC patients diagnosed in 2000-2007 and followed-up to 12/31/2008. RS trends in 1999-2007 and 10-year RS in 2005-2007 were estimated using the period approach. RESULTS: In Europe 2000-2007, 5-year RS after TC was 88% in women and 81% in men. Survival rates varied by country and were strongly correlated (Pearson ρ = 75%) with country-specific incidence rates. Five-year RS decreased with age (in women from >95% at age 15-54 to 57% at age 75+), from 98% in women and 94% in men with papillary TC to 14% in women and 12% in men with anaplastic TC. Proportion of papillary TC varied by country and increased over time, while survival rates were similar across areas and periods. In 1999-2007, 5-year RS increased by five percentage points for all TCs but only by two for papillary and by four for follicular TC. Ten-year RS in 2005-2007 was 89% in women and 79% in men. CONCLUSIONS: The reported increasing TC survival trend and differences by area are mainly explained by the varying histological case-mix of cases.

Trends in incidence and survival analysis in non-melanoma skin cancer from 1994 to 2012 in Girona, Spain: A population-based study.

INTRODUCTION: We present an epidemiological study focused on Non-melanoma skin cancers (NMSC), including squamous cell carcinoma (SCC), basal cell carcinoma (BCC), Merkel cell carcinoma (MCC), dermatofibrosarcoma protuberans (DFS) and adnexal and skin appendages neoplasm (ASAN), a neoplasm understudied in cancer registries. MATERIAL AND METHODS: We analyze trends of incidence and survival of NMSC registered with the Cancer Registry of Girona, Spain. RESULTS: We found 14389 cases of NMSC, accounting 3,474 SCC, 10729 BCC, 33 MCC, 61 DFSP and 71 ASAN. Incidence increased significantly in SCC and BCC with annual percentage of change of 1.6 and 1.5, respectively, but not in MCC, DFS or ASAN. Five-year relative survival for both sexes was 90.1% in SCC, 99.8% in BCC, 44.2% in MCC, 93.7% in DFS and 84% in ASAN. CONCLUSIONS: Our study confirms the increasing incidence and good survival of SCC and BCC and enhances knowledge on the epidemiology of the less incidental NMSC.

Temporal trends of incidence and survival of sarcoma of digestive tract including Gastrointestinal Stromal Tumours (GIST) in two areas of the north-east of Spain in the period 1981-2005: a population-based study

INTRODUCTION: The diagnostic approach of Gastrointestinal Stromal Tumours (GIST) was established in 2002. Before this, GIST had been classified with a wide range of histological terms. This fact and the consideration of potential malignity of all these tumours led to a false perception of an increasing incidence. PURPOSE: This study aimed at evaluating the accuracy in registration of sarcoma of digestive tract and GIST and to elucidate the trends of incidence and survival of those. MATERIALS AND METHODS: We used data from two population-based cancer registries in Spain. In the Girona's Cancer Registry we previously reclassified all sarcoma of digestive tract performing c-kit to confirm GIST and analysed the time period 1994-2005. In Tarragona's Cancer Registry, where we analysed the time period 1981-2005, this reclassification was not done. RESULTS: We obtained a significant increasing trend in incidence of all sarcoma of digestive tract in the Tarragona Cancer Registry database, with an annual per cent of change of 3.87 but a non-statistically significant trend in incidence in the Girona Cancer Registry database. The incidence of GIST in Girona Cancer Registry was 1.24 cases/100,000 inhabitants/year. Survival rates did not change in time and was high in less aggressive GIST. The 5-year relative survival for low, intermediate and high risk of malignant behaviour GIST groups were, respectively, 80.5, 85.6 and 64.6 %. CONCLUSIONS: The increase in the incidence of GIST could be explained by the improvement in their diagnosis and registration. The survival of low and intermediate risk of malignant behaviour is high and close to normal population survival (AU)

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Temporal trends of incidence and survival of sarcoma of digestive tract including Gastrointestinal Stromal Tumours (GIST) in two areas of the north-east of Spain in the period 1981-2005: a population-based study.

INTRODUCTION: The diagnostic approach of Gastrointestinal Stromal Tumours (GIST) was established in 2002. Before this, GIST had been classified with a wide range of histological terms. This fact and the consideration of potential malignity of all these tumours led to a false perception of an increasing incidence. PURPOSE: This study aimed at evaluating the accuracy in registration of sarcoma of digestive tract and GIST and to elucidate the trends of incidence and survival of those. MATERIALS AND METHODS: We used data from two population-based cancer registries in Spain. In the Girona's Cancer Registry we previously reclassified all sarcoma of digestive tract performing c-kit to confirm GIST and analysed the time period 1994-2005. In Tarragona's Cancer Registry, where we analysed the time period 1981-2005, this reclassification was not done. RESULTS: We obtained a significant increasing trend in incidence of all sarcoma of digestive tract in the Tarragona Cancer Registry database, with an annual per cent of change of 3.87 but a non-statistically significant trend in incidence in the Girona Cancer Registry database. The incidence of GIST in Girona Cancer Registry was 1.24 cases/100,000 inhabitants/year. Survival rates did not change in time and was high in less aggressive GIST. The 5-year relative survival for low, intermediate and high risk of malignant behaviour GIST groups were, respectively, 80.5, 85.6 and 64.6 %. CONCLUSIONS: The increase in the incidence of GIST could be explained by the improvement in their diagnosis and registration. The survival of low and intermediate risk of malignant behaviour is high and close to normal population survival.

Amaurosis cortical transitoria por Metotrexato. A propósito de un caso / Transient cortical blindness due to Methotrexate. Report of a case

Propósito: Presentar un caso de amaurosis bilateral en el contexto de una encefalopotía metabólica en una paciente tratada por un linfoma de alto grado de malignidad mediante un esquema de poliquimioterapia que incluía Citarabina, Vincristina y Metotrexato como principales drogas neurotóxicas. Material y métodos: Paciente de 29 años que presentó una amaurosis cortical bilateral en el contexto de un síndrome de lisis tumoral tras administración de quimioterapia, comprometiéndose el aclaramiento plasmático de Metotrexato, citostático al que atribuimos la clínica neurológica que se describe y analiza. Resultado: La neurotoxicidad revirtió completamente tras el tratamiento de rescate con Leucovorin. Conclusiones: La amaurosis cortical es un tipo de toxicidad neurológica aguda del Metotrexato transitoria y reversible. Su tratamiento se basa en el soporte hemodinámico y el uso de Leucovorin (AU)