Comella P.,National Tumour Institute |
Chiuri V.E.,Vito Fazi Hospital |
De Cataldis G.,Da Procida Hospital |
Filippelli G.,San Francesco di Paola Hospital |
And 10 more authors.
Lung Cancer | Year: 2010
Purpose: To estimate the safety, activity, and impact on quality of life of a combination of gemcitabine and pemetrexed in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in the context of a randomized two-stage phase II study. Patients and methods: Patients in stage IIIB or IV NSCLC were randomly allocated to receive either gemcitabine 1250 mg/m2 on day 1, and pemetrexed (Alimta) 500 mg/m2 followed by gemcitabine 1250 mg/m2 on day 8 of a 3-weekly cycle (GA arm), or paclitaxel 120 mg/m2 followed by gemcitabine 1000 mg/m2, both given on days 1 and 8 of a 3-weekly cycle (PG arm). Results: 105 (GA arm, 51; PG arm, 54) eligible patients (stage IV, 32 and 30, respectively) were enrolled into this study; thereafter, accrual was stopped due to first-stage analysis. The response rate was 20% (95% confidence interval [CI], 10-33%) in the GA arm, and 32% (95% CI, 20-46%) in the PG arm. Median progression-free survival was 5.1 (95% CI, 3.7-6.5) months in the GA arm, and 8.3 (95% CI, 5.9-10.7) months in the PG arm, while median overall survival was 10.5 (95% CI 7.1-13.9), and 13.3 (95% CI 11.7-14.9) months, respectively. Severe neutropenia (36% vs 22%), and febrile neutropenia (14% vs 7%) were more common with the GA regimen, while hair loss (52% vs 16%) and any grade peripheral neuropathy (31% vs 2%) occurred more frequently with PG regimen. Other severe side effects of GA regimen were diarrhoea (10%), liver enzyme derangement (10%), and fatigue (8%). Conclusion: The GA regimen was tolerated and moderately active in advanced or metastatic NSCLC. However, this combination did not yield any advantage in comparison with the PG regimen, and does not deserve further evaluation. © 2009 Elsevier Ireland Ltd. All rights reserved. Source
Alonso-Ruano M.,Dr. Josep Trueta Hospital of Girona |
Lopez-Bonet E.,Dr. Josep Trueta Hospital of Girona |
Victoria-Anaya M.H.,Figueres Hospital |
Vila-Camps E.,Dr. Josep Trueta Hospital of Girona |
And 5 more authors.
Oncology Letters | Year: 2013
Neuroendocrine tumors (NETs) are frequently associated with second primary malignancies (SPMs). Earlier studies have demonstrated that NETs are highly associated with synchronous or metachronous gastrointestinal and genitourinary SPMs. We report, for the first time, a case of pure NE breast carcinoma (NEBC) exhibiting all of the World Health Organization (WHO)-categorized morphological and phenotypic NE features (i.e., round solid nests of spindle cells, plasmacytoid cells, large clear or mucinous signet-ring cells with a peripheral palisading tendency and immunohistochemical positivity for the NE markers synaptophysin and chromogranin in more than 50% of the tumor cell population) along with synchronous abdominal non-Hodgkin's lymphoma. In the present study, we review the diagnosis, clinicopathological features and histogenetic profiling of NEBC and discuss the literature relevant to the clinical and anatomopathological management of this case. This previously unreported case of synchronous solid NEBC and abdominal lymphoma, together with earlier studies showing that primary symptoms are caused by SPMs in a significant subgroup of NET patients, strongly supports the notion that NETs should be cautiously considered to be index tumors. Therefore, risk-adapted clinicopathological follow-up with systematic investigation is strongly recommended. Source