Jpn. J. Clin. Oncol. (2012) 42 (9): 836-844.

The primary efficacy end point was investigator assessed clinical benefit rate (CBR), defined as the proportion of patients with a complete response (CR) or partial response (PR) or stable disease (SD) ≥24 weeks according to RECIST (15). Tumor assessments were scheduled every 8 weeks until disease progression. Secondary end points included PFS, objective response rate (ORR; CR + PR), duration of response, time to treatment failure (TTF) and OS. Subgroup analyses for key efficacy end points were also performed for exploratory purposes.

Jpn. J. Clin. Oncol. (2012) 42 (9): 836-844.

Safety and tolerability were evaluated at regular intervals using the following assessments: monitoring of AEs, serious AEs and withdrawals or treatment modification due to AEs; physical examinations; laboratory assessments; ECG; ECHO or MUGA scan; PFTs; oxygen saturation; CT scans and concomitant medications for management of AEs. Severity of AEs was graded using CTCAE version 3.0.

Jpn. J. Clin. Oncol. (2012) 42 (9): 836-844.

The study was planned to include ∼80 patients (20 Japanese, 30 Chinese and 30 Korean). The null hypothesis (uninteresting CBR) was set at 20% and the alternative hypothesis (sufficiently promising CBR) was set at 40%. With a sample size of 80 patients, there was an ∼97% chance that the 95% CI for the CBR excluded 20% when the true rate was 40%. The number of patients in each country was based on clinical considerations.

J Transl Med. 2012; 10: 141.

This study was approved by the institutional review board at each University (Approval Number at University of Yamanashi of Principal Investigator, No.484) and was registered with ClinicalTrials.gov, number NCT00995358. Written informed consent was obtained from all participants. The trial was carried out in accordance with the Helsinki declaration on experimentation on human subjects.

BMC Cancer. 2011; 11: 182.

IMRTRadiotherapy of head and neck cancer is commonly accompanied by marked side-effects. Modern techniques have shown to significantly reduce long-term sequelae of the treatment [11-13] and have rapidly been integrated into routine clinical practice. Techniques such as intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) facilitate application of higher doses due to stepp gradients and hence higher conformality and improved sparing of normal tissues. Despite relative dose escalation, acute and late toxicity can be reduced. A recent phase III trial comparing IMRT versus conventional RT could clearly demonstrate a significant advantage of IMRT in reducing the rate of xerostomia [14]. In order to reduce toxicity and therefore improve radiotherapy regimens, integration of modern radiotherapy techniques into potential new trial designs is of fundamental importance.

BMC Cancer. 2011; 11: 182.

Safety parametersAdverse events are defined as any untoward medical occurrence in a patient from the beginning of radioimmunotherapy (day 57) up to the follow-up visit 12 months post completion of combined radioimmunotherapy. All adverse events under standard induction chemotherapy and prior to the first administration of cetuximab will be recorded as medical history. Adverse Events will be reported using NCI CTCAE v4.0.

BMC Cancer. 2011; 11: 182.

Intensity-modulated radiotherapy (IMRT)Radiotherapy will be given to the patients only as intensity modulated radiotherapy (IMRT) and must be used for the entire course of treatment. Intensity-modulated RT is planned using two commercially available planning systems: KonRad (Siemens OS) for step-and-shoot applications or Tomotherapy®. IMRT hence is delivered either at a 6 MV-linear accelerator (step-and-shoot technique) or at a 6 MV tomotherapy unit to a total dose of 50 Gy in 2 Gy/fraction. IMRT image guidance consists of MV cone-beam CTs which are taken into account for the calculation of the total applied dose.

Gynecol Oncol. 2012 April; 125(1): 136–140.

A phase II study single agent of aflibercept (VEGF Trap) in patients with recurrent or metastatic gynecologic carcinosarcomas and uterine leiomyosarcoma. A trial of the Princess Margaret Hospital, Chicago and California Cancer Phase II ConsortiaEvaluation of toxicity and tumor responseBaseline evaluations included medical history, physical examination, laboratory tests (hematology, urinalysis, coagulation, blood chemistry), ECG (if indicated), and pregnancy test and were performed within 7 days of administration of protocol therapy. Physical exam, lab tests (hematology, biochemistry and urinalysis), evaluation of toxicity according to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3 were performed on day 1 of each cycle. Blood pressure and pulse were measured every cycle with measurements made prior to commencing aflibercept, at 30 minutes into the infusion and 30 minutes post infusion during cycle 1 and 2. Radiologic assessment of measureable disease was performed by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to registration and every 4 cycles (8 weeks). Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST) [23].

Gynecol Oncol. 2012 April; 125(1): 136–140.

A phase II study single agent of aflibercept (VEGF Trap) in patients with recurrent or metastatic gynecologic carcinosarcomas and uterine leiomyosarcoma. A trial of the Princess Margaret Hospital, Chicago and California Cancer Phase II Consortia The study was conducted according to Good Clinical Practice guidelines, with full research ethics board approval at each of the participating institutions. All patients provided written informed consent before study entry. The two cohorts were enrolled simultaneously and independently.