Common Terminology Criteria For Adverse Events V4 Research Articles

Ipsilateral irradiation for well lateralized carcinomas of the oral cavity and oropharynx: results on tumor control and xerostomia

BackgroundIn head and neck cancer, bilateral neck irradiation is the standard approach for many tumor locations and stages. Increasing knowledge on the pattern of nodal invasion leads to more precise targeting and normal tissue sparing. The aim of the present study was to evaluate the morbidity and tumor control for patients with well lateralized squamous cell carcinomas of the oral cavity and oropharynx treated with ipsilateral radiotherapy.MethodsTwenty consecutive patients with lateralized carcinomas of the oral cavity and oropharynx were treated with a prospective management approach using ipsilateral irradiation between 2000 and 2007. This included 8 radical oropharyngeal and 12 postoperative oral cavity carcinomas, with Stage T1-T2, N0-N2b disease. The actuarial freedom from contralateral nodal recurrence was determined. Late xerostomia was evaluated using the European Organization for Research and Treatment of Cancer QLQ-H&N35 questionnaire and the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.ResultsAt a median follow-up of 58 months, five-year overall survival and loco-regional control rates were 82.5% and 100%, respectively. No local or contralateral nodal recurrences were observed. Mean dose to the contralateral parotid gland was 4.72 Gy and to the contralateral submandibular gland was 15.30 Gy. Mean score for dry mouth was 28.1 on the 0-100 QLQ-H&N35 scale. According to CTCAE v3 scale, 87.5% of patients had grade 0-1 and 12.5% grade 2 subjective xerostomia. The unstimulated salivary flow was > 0.2 ml/min in 81.2% of patients and 0.1-0.2 ml/min in 19%. None of the patients showed grade 3 xerostomia.ConclusionIn selected patients with early and moderate stages, well lateralized oral and oropharyngeal carcinomas, ipsilateral irradiation treatment of the primary site and ipsilateral neck spares salivary gland function without compromising loco-regional control.

Association of progression‐free survival, overall survival, and patient‐reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy

The authors explored the association of skin toxicity (ST) severity as measured by patient-reported ST and Common Terminology Criteria for Adverse Events (CTCAE) grading with efficacy of panitumumab, a fully human antiepidermal growth factor receptor antibody, from a phase 3 metastatic colorectal cancer (CRC) trial. Patients were randomized to panitumumab plus best supportive care (BSC) vs BSC alone. ST by modified National Cancer Institute CTCAE v3.0 and modified Dermatology Life Quality Index (mDLQI), health-related quality of life (HRQOL), and CRC symptoms were measured. ST was analyzed using a landmark approach. Associations by KRAS mutational status were also assessed. Of 463 patients, 208 of 231 (90%) panitumumab patients and 184 of 232 (79%) BSC patients had > or = 1 postbaseline patient-reported outcome (PRO) assessment. Panitumumab patients with more severe ST had significantly longer overall survival (OS) (grade 2-4:grade 1; hazard ratio, 0.60; P = .0033). Lower mDLQI scores (< 67; more bothersome ST) were associated with longer OS (Cox model, P < .0001). Similar results were observed with progression-free survival (PFS). An inverse relation between mDLQI and HRQOL scores was observed, suggesting that ST bother correlated with better HRQOL. KRAS and PRO data were available in 363 patients (188 panitumumab; 175 BSC). Longer OS was associated with lower mDLQI scores, regardless of KRAS status. Longer PFS was associated with more severe ST (lower mDLQI scores and higher CTCAE grade ST) in patients with wild-type (WT) KRAS tumors, but not in patients with mutant KRAS tumors. More severe ST, by both clinical grading and PRO, is associated with better CRC symptoms and HRQOL and with longer OS and PFS among panitumumab-treated patients. The associations for PFS were more pronounced in patients with WT KRAS tumors.

Grading-System-Dependent Volume Effects for Late Radiation-Induced Rectal Toxicity After Curative Radiotherapy for Prostate Cancer

To assess the association between the dose distributions in the rectum and late Radiation Therapy Oncology Group and the European Organisation for Research and Treatment of Cancer (RTOG/EORTC), Late Effects of Normal Tissue SOMA, and Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 graded rectal toxicity among patients with prostate cancer treated with RT. Included in the study were 124 patients who received three-dimensional conformal RT for prostate cancer to a total dose of 70 Gy in 2-Gy fractions. All patients completed questionnaires regarding rectum complaints before RT and during long-term follow-up. Late rectum Grade 2 or worse toxicity, according to RTOG/EORTC, LENT SOMA, and CTCAE v3.0 criteria, was analyzed in relation to rectal dose and volume parameters. Dose-volume thresholds (V40>or=65%, V50>or=55%, V65>or=45%, V70>or=20%, and a rectum volume<or=140 cm3), significantly discriminated patients with late Grade 0-1 and Grade 2 or worse rectal toxicity, particularly using the LENT SOMA and CTCAE v3.0 systems. The rectum volume receiving>or=70 Gy (V70) was most predictive for late Grade 2 or worse rectal toxicity with each of the grading systems. The associations were strongest, however, with use of the LENT SOMA system. Volume effects for late radiation-induced rectal toxicity are present, but their clinical significance depends on the grading system used. This should be taken into account in the interpretation of studies reporting on radiation-induced rectal toxicity.

The NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 is the new standard for oncology clinical trials

6098 Background: A need for reproducible, consistent and readily usable adverse event reports led the World Health Organization in 1979 to create a scale for adverse event (AE) description and grading. As the cancer clinical trials endeavor has become more complex, there has been a need for more complex yet easy to use AE criteria. The NCI published its 1st and 2nd versions of the CTC in 1982 and 1998 in response to this need. In 2001 The Cancer Therapy Evaluation Program of the NCI, in response to requersts from investigators, intiatated an effore to update the CTC. Methods: This updated version of naming and grading of adverse events in cancer clinical trials is the result of collaboration among academic, governmental, and pharmaceutical industry clinical investigators. The drafts of the CTCAE v3 were reviewed twice by more than 400 reviewers. Results: The CTCAE v. 3 was launched on the CTEP web site http://ctep.cancer.gov/reporting/ctc.html on June 10, 2003 and is used for all new NCI- sponsored clinic...

The NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 is the new standard for oncology clinical trials

6098 Background: A need for reproducible, consistent and readily usable adverse event reports led the World Health Organization in 1979 to create a scale for adverse event (AE) description and grading. As the cancer clinical trials endeavor has become more complex, there has been a need for more complex yet easy to use AE criteria. The NCI published its 1st and 2nd versions of the CTC in 1982 and 1998 in response to this need. In 2001 The Cancer Therapy Evaluation Program of the NCI, in response to requersts from investigators, intiatated an effore to update the CTC. Methods: This updated version of naming and grading of adverse events in cancer clinical trials is the result of collaboration among academic, governmental, and pharmaceutical industry clinical investigators. The drafts of the CTCAE v3 were reviewed twice by more than 400 reviewers. Results: The CTCAE v. 3 was launched on the CTEP web site http://ctep.cancer.gov/reporting/ctc.html on June 10, 2003 and is used for all new NCI- sponsored clinical trials as of October 2003. The CTCAE v.3 contains 28 categories and 1056 specific adverse event terms, as compared to 24 and 395 respectively in the CTC v.2. Major changes include the elimination of duration and time- dependent grading of adverse events, integration of acute and late effects into one scoring system, and expansion of criteria relevant to surgical, radiation, and pediatric trials. The creation of supra-ordinate terms allows for greater site and organ specificity, especially in the categories of pain, infection, gastrointestinal and musculoskeletal adverse events. Conclusions: A direct mapping between CTCAE versions 2 and 3 is available to facilitate translation from one system to another . Additionally, both versions of the CTCAE have been mapped to the Medical Dictionary for Regulatory Activities (MedDRA™) for regulatory reporting purposes. It is anticipated that the CTCAE v.3 will replace v. 2 as the world standard for reporting of AEs in cancer clinical trials. The ASCO presentation will focus on changes to the CTCAE, comparisons with the older versions, and implications for AE recording and evaluation. No significant financial relationships to disclose.