Peter Petrow

Phase II Study of Cetuximab As First-Line Single-Drug Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin

PURPOSE To evaluate the efficacy and safety of cetuximab, a monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR), as a first-line monotherapy in patients with unresectable squamous cell carcinoma of the skin (SCCS). PATIENTS AND METHODS Thirty-six patients received cetuximab (initial dose of 400 mg/m(2) followed by subsequent weekly doses of 250 mg/m(2)) for at least 6 weeks with a 48-week follow-up. The primary end point was the disease control rate (DCR) at 6 weeks (according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria). Secondary end points included best response rate, overall survival, progression-free survival (PFS), and toxicity assessment. Association of treatment efficacy with RAS mutations or FcγR genotypes was investigated. RESULTS Median age of the study population was 79 years. DCR at 6 weeks was obtained in 25 of 36 patients (69%; 95% CI, 52% to 84%) of the intention-to-treat population. The best responses were eight partial responses and two complete responses. There were no cetuximab-related deaths. There were three related serious adverse events: two grade 4 infusion reactions and one grade 3 interstitial pneumopathy. Grade 1 to 2 acne-like rash occurred in 78% of patients and was associated with prolonged PFS. One HRAS mutation was identified. Combined FcγRIIa-131H/H and/or FcγRIIIa-158V/V polymorphisms were not associated with the clinical outcomes. CONCLUSION As a first-line treatment in patients with unresectable SCCS, cetuximab achieved 69% DCR. A randomized phase III trial is warranted to confirm that cetuximab may be considered as a therapeutic option especially in elderly patients. The low frequency of RAS mutations in SCCS makes SCCS tumors attractive for EGFR inhibition.

Surveillance de l'endomètre des femmes sous tamoxifène

Tamoxifen estrogenic action in the uterus induces several uterine diseases, benign and/or malignant ones. The risk of endometrial adenocarcinoma is multiplied by two to three in post-menopausal women. It is mainly linked with the doses and the length of the treatment. However, the global benefit of that drug is not questioned anymore. What matters now though is to find the best way to follow patients on tamoxifen. As a matter of fact, there is no such thing as a consensus that would include specific tests, nor a surveillance protocol in women on tamoxifen. Most teams do not propose any special follow-up. Some patients already show uterine anomalies prior to the beginning of tamoxifen treatment. A yearly gynecologic examination, together with a cervico-vaginal smear, is enough when there are no specific endometrial adenocarcinoma risk factors, nor anomalies detected during the pre-therapeutical evaluation, nor clinical symptomatology. In case of risk factors, or cervical stenosis, or again initial abnormalities though, a yearly transvaginal sonography may be proposed. There is no need for other exploratory examinations if the results are satisfying. In case of symptoms, anomalies in the cervico-vaginal smears, intra-uterine liquid retention with a stenosed cervix, or suspicious endometrial thickness, then an endometrial sampling must be carried out. MRI could be of interest in asymptomatic patients with unclear ultrasonography images. Follow-up must be continued after interruption of tamoxifen. It is important to inform patients about the additional risks of developing an endometrial cancer because of tamoxifen, while still being reassuring. Besides, it is absolutely necessary to recommend them to take quickly medical advice in case of gynecologic symptoms.

Hyperselective intra-arterial preoperative chemotherapy in patients with squamous cell carcinoma of the oral cavity: preliminary results

OBJECTIVES To investigate radiological response and findings after Intra Arterial Chemotherapy (IAC) for patients with Squamous Cell Carcinoma (SCC) of the oral cavity. MATERIALS AND METHODS Patients received 1-2 cycles of IAC. Radiological assessment was performed on day 7 and day 21 after each cycle using CT scan and MRI. RESULTS Six patients (median age: 52, ranging 46-60; male/female: 5/1) received 10 cycles (4 patients received 2 cycles). Primary tumors were floor of the mouth (4 patients) and oral tongue (2 patients). TNM classification was T2N0-2b in 3 patients and T4N0-1 in 3 patients. All patients had good locoregional/systemic tolerance and 3 showed clinical objective response (OR). Four patients were evaluable on both CT and MRI, 1 patient on MRI only and 1 patient did not tolerate imaging. Three patients showed OR both on CT and MRI, 1 patient showed stable disease (SD) on CT and OR on MRI and 1 patient showed SD on MRI. Contrast-enhancement of hemiperfused tongue was reported in all evaluable patients. Two patients presented intratumoral necrosis and 5 patients displayed local edema (MRI). One patient had modification of the sternocleidomastoid muscle after IAC. CONCLUSION Radiological modifications were observed in the infused area and correlated well with clinical response. This study is ongoing.