First-line mFOLFOX plus cetuximab followed by mFOLFOX plus cetuximab or single-agent cetuximab as maintenance therapy in patients with metastatic colorectal cancer: Phase II randomised MACRO2 TTD study.

BACKGROUND: This multicentre, randomised, and phase II study evaluated mFOLFOX+cetuximab followed by maintenance mFOLFOX+cetuximab or single-agent cetuximab in metastatic colorectal cancer (mCRC) patients (NCT01161316). PATIENTS AND METHODS: Previously, untreated mCRC patients (wild-type KRAS) were randomised to receive cetuximab+mFOLFOX-6 (8 cycles for 2 weeks) followed by maintenance therapy: single-agent cetuximab (Arm-A) or mFOLFOX-6 + cetuximab (Arm-B) until progression. Primary endpoint was progression-free survival (PFS) at 9 months. RESULTS: One hundred ninety-three patients (median [range] age 60 [33-74] years) were randomised (2:1): 129 Arm-A versus 64 Arm-B. PFS at 9 months (95% confidence interval) showed non-inferiority between arms (Arm-A/Arm-B: 60 [52, 69]%/72 [61, 83]%, p [non-inferiority]<0.1). There were no statistically significant differences in the PFS (Arm-A/Arm-B: 9 [95% CI 7, 10] months/10 [7,13] months, hazard ratio [HR] = 1.19 [0.80, 1.79]) or overall survival (23 [19, 28] months/27 [18, 36] months, HR = 1.24 [0.85, 1.79]) between arms. The objective response rate was also similar (48 [39, 57]%/39 [27, 52]%). The safety profile was similar between arms, and all patients experienced at least one adverse event (AE) (Arm-A/Arm-B grade ≥III AEs: 70%/68%). The most common grade ≥III AEs were as follows: neutropenia (Arm-A/Arm-B: 28%/26%), rash acneiform (15%/24%) and sensory neuropathy (2%/15%) in any group. Arm-A was associated with less grade ≥III rash and sensory neuropathy and a lower rate of serious AEs (20%/27%). CONCLUSION(S): This phase II exploratory trial with a non-inferiority design suggests that maintenance therapy with single-agent cetuximab following mFOLFOX+cetuximab induction could be a valuable option compared with mFOLFOX+cetuximab treatment continuation. We await phase III trials to confirm single-agent cetuximab as maintenance therapy in mCRC patients.

[Current state of adjuvant treatment to surgery in the initial stages of nonsmall cell lung cancer]. / Estado actual del tratamiento adyuvante a la cirugía en los estadios iniciales del cáncer de pulmón no microcítico.

The results of the recently performed randomised trials support the conclusion that adjuvant chemotherapy confers survival advantage in early stage in non-small cell lung cancer, and now has become the standard of care for patients with resected stage II and IIIA. The role of adjuvant chemotherapy for stage I disease remains controversial. Only some patients benefit from systemic adjuvant therapy and we need to identify factors of patients most likely to respond to chemotherapy. The purpose of this article is to provide a general overview of adjuvant chemotherapy for early stage in non-small cell lung cancer.

[Prevalence of hepatitis C virus infection in patients with non-Hodgkin's lymphoma]. / Prevalencia de infección por el virus de la hepatitis C en pacientes con linfomas no hodgkinianos.

BACKGROUND: To know the prevalence of HCV infection in patients diagnosed with B-NHL in our area. PATIENTS AND METHOD: A group of patients diagnosed with B-NHL between 1998-99 were carefully reviewed (serological tests, HCV RNA, laboratory studies, toxicity, response to treatment and evolution) in a transversal study. RESULTS: Overall 9/77 (11.68%) of patients tested positive for HCV. Of the 9 patients HCV(+) showed abnormal elevated trans aminases in opposition with 10.3% of patients that tested seronegative. CONCLUSION: Compared with normal individuals, we have seen a higher prevalence of HCV in our B-NHL patients. It may be possible that HCV play a role in that lymphoma's pathogenesis.