Non-small cell lung cancer clinical practice guidelines in oncology.
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Humans↗
Biomedical subjects
Mohammad Jahanzeb
Publications and source records attributed to Mohammad Jahanzeb.
Venous thromboembolic disease. Clinical practice guidelines in oncology.
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Female↗
HER2 testing in breast cancer: NCCN Task Force report and recommendations.
The NCCN HER2 Testing in Breast Cancer Task Force was convened to critically evaluate the ability of the level of HER2 expression or gene amplification in breast cancer tumors to serve as a prognostic and a predictive factor in the metastatic and adjuvant settings, to assess the reliability of the methods of measuring HER2 expression or gene amplification in the laboratory, and to make recommendations regarding the interpretation of test results. The Task Force is a multidisciplinary panel of 24 experts in breast cancer representing the disciplines of medical oncology, pathology, radiation oncology, surgical oncology, epidemiology, and patient advocacy. Invited members included members of the NCCN Breast Cancer Panel and other needed experts selected solely by the NCCN. During a 2-day meeting, individual task force members provided didactic presentations critically evaluating important aspects of HER2 biology and epidemiology: HER2 as a prognostic and predictive factor; results from clinical trials in which trastuzumab was used as a targeted therapy against HER2 in the adjuvant and metastatic settings; the available testing methodologies for HER2, including sensitivity, specificity, and ability to provide prognostic and predictive information; and the principles on which HER2 testing should be based. Each task force member was charged with identifying evidence relevant to their specific expertise and presentation. Following the presentations, an evidence-based consensus approach was used to formulate recommendations relating to the pathologic and clinical application of the evidence to breast cancer patient evaluation and care. In areas of controversy, this process extended beyond the meeting to achieve consensus. The Task Force concluded that accurate assignment of the HER2 status of invasive breast cancer is essential to clinical decision making in the treatment of breast cancer in both adjuvant and metastatic settings. Formal validation and concordance testing should be performed and reported by laboratories performing HER2 testing for clinical purposes. If appropriate quality control/assurance procedures are in place, either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) methods may be used. A tumor with an IHC score of 0 or 1+, an average HER2 gene/chromosome 17 ratio of less than 1.8, or an average number of HER2 gene copies/cell of 4 or less as determined by FISH is considered to be HER2 negative. A tumor with an IHC score of 3+, an average HER2 gene/chromosome 17 ratio of greater than 2.2 by FISH, or an average number of HER2 gene copies/cell of 6 or greater is considered HER2 positive. A tumor with an IHC score of 2+ should be further tested using FISH, with HER2 status determined by the FISH result. Tumor samples with an average HER2 gene/chromosome ratio of 1.8 to 2.2 or average number of HER2 gene copies/cell in the range of greater than 4 to less than 6 are considered to be borderline, and strategies to assign the HER2 status of such samples are proposed.
Advisory Committees↗
A process for measuring the quality of cancer care: the Quality Oncology Practice Initiative.
PURPOSE: The Quality Oncology Practice Initiative (QOPI) is a practice-based system of quality self-assessment sponsored by the participants and the American Society of Clinical Oncology (ASCO). The process of quality evaluation, development of the pilot questionnaire, and preliminary results are reported. METHODS: Physicians from seven oncology groups developed medical record abstraction measures based on practice guidelines and consensus-supported indicators of quality care. Each practice completed two rounds of records review and received practice and aggregate results. Mean frequencies of responses for each indicator were compared among practices. RESULTS: Participants universally, if informally, find QOPI helpful, and results show statistically significant variation among practices for several indicators, including assessing pain in patients close to death, documentation of informed consent for chemotherapy, and concordance with granulocytic and erythroid growth factor administration guidelines. Measures with universally high concordance include the use of serotonin antagonist antiemetics according to the ASCO guideline; the presence of a pathology report in the record; the use of chemotherapy flow sheets; and adherence to standard chemotherapy recommendations for patients with certain stages of breast, colon, and rectal cancer. Concordance with quality indicators significantly changed between survey rounds for several measures. CONCLUSION: Pilot results indicate that the QOPI process provides a rapid and objective measurement of practice quality that allows comparisons among practices and over time. It also provides a mechanism for measuring concordance with published guidelines. Most importantly, it provides a tool for practice self-examination that can promote excellence in cancer care.
Data Collection↗
Efficacy and safety of liposomal anthracyclines in phase I/II clinical trials.
Preclinical studies have established the pharmacologic advantages of liposomal anthracyclines, including pharmacokinetic profiles after bolus dosing that resemble continuous infusion of conventional anthracyclines, increased drug concentrations in tumor cells compared with the surrounding tissues, and reduced toxicity relative to conventional anthracycline treatment. Based on these studies, many phase I and phase II clinical trials were conducted to assess the safety and potential activity of liposomal anthracyclines in the management of both solid and hematologic tumors. These studies provided valuable insight into the safety of pegylated liposomal doxorubicin (Doxil/Caelyx [PLD]), nonpegylated liposomal doxorubicin (Myocet [NPLD]), and liposomal daunorubicin (DaunoXome [DNX]) over a range of doses, either as single-agent therapy or in combination with other cytotoxic agents. Other liposomal anthracyclines in development may be well tolerated but their activity remains to be elucidated by clinical trials. The available data also suggest that liposomal anthracyclines have activity not only against tumor types with known sensitivity to conventional anthracyclines, but also potentially for tumors that are typically anthracycline-resistant. Despite the availability of clinical data from a wide variety of tumor types and patient populations, further studies of liposomal anthracycline therapy are needed to fully establish their safety, efficacy, and dosing in the treatment of these patients.
Antibiotics, Antineoplastic↗
Trastuzumab-based combinations in metastatic breast cancer: how to make a choice.
Trastuzumab, a humanized monoclonal anti-human epidermal growth factor receptor-2 (HER2) antibody that has proven efficacy as monotherapy in HER2-overexpressing breast cancer, has a favorable toxicity profile characterized by infrequent infusion reactions and a slightly increased incidence of cardiac dysfunction. Regimens that combine trastuzumab with a cytotoxic agent can increase the overall response rate and prolong survival in patients with metastatic breast cancer. Trastuzumab has been investigated in combination with anthracyclines, taxanes, platinum salts, vinorelbine, gemcitabine, capecitabine, and combinations of these agents. Combining trastuzumab with these agents enhances the toxicity of treatment and can especially enhance the risk of cardiotoxicity. This article summarizes data on trastuzumab-based combinations with particular attention to the risk benefit ratio of these therapies. HER2 testing by immunohistochemistry or fluorescence in situ hybridization is discussed in the context of determining the optimal course of treatment for patients.
Antibodies, Monoclonal↗
Phase II trial of weekly vinorelbine and trastuzumab as first-line therapy in patients with HER2(+) metastatic breast cancer.
PURPOSE: Human epidermal growth factor receptor 2 (HER2) overexpression is associated with a more aggressive form of breast cancer that responds well to trastuzumab therapy. Trastuzumab-based combination regimens have shown greater antitumor activity than chemotherapy alone. These findings, coupled with the favorable antitumor activity and tolerability profile of vinorelbine in breast cancer, provided the rationale for investigating the novel combination of vinorelbine and trastuzumab. PATIENTS AND METHODS: A phase II, open-label trial of intravenous vinorelbine (30 mg/m(2) on day 1, then weekly) and trastuzumab (4 mg/kg on day 0, then 2 mg/kg weekly) was conducted in previously untreated HER2(+) metastatic breast cancer patients. Vinorelbine dose was adjusted for grade 3/4 neutropenia; patients remained on combination therapy until disease progression or patient withdrawal due to adverse events. RESULTS: Of 40 enrolled patients (median age 51 years, range 30-82), 37 were evaluable for response. Overall response rate was 78% (29/37, 95% confidence interval [CI] 62%-90%), including four (11%, 95% CI 3%-25%) complete and 25 (68%) partial responses. Objective tumor response correlated with degree of HER2 positivity: immunohistochemistry (IHC) 3(+) = 82% (18/22) response and IHC 2(+) = 58% (7/12) response. Median time to progression was 72 weeks (95% CI 37-138 weeks); median survival has not been reached. Grade 3/4 neutropenia was the most frequent serious toxicity and cause of dose reductions (9% of courses) and omissions (10% of courses). No patient experienced serious cardiac toxicity. CONCLUSIONS: Weekly vinorelbine/trastuzumab offers a high therapeutic index as initial therapy in patients with HER2(+) metastatic breast cancer. Further investigation of this novel regimen is planned.
Adult↗
Docetaxel and carboplatin as first-line therapy in advanced non-small cell lung carcinoma: a phase II study.
BACKGROUND: Taxanes have been widely used against advanced non-small cell lung cancer (NSCLC), alone and in combination with platinum agents. In order to develop a tolerable palliative regimen, we combined carboplatin with low dose docetaxel. PATIENTS AND METHODS: Chemotherapy-naive patients, with Stage IIIB or IV NSCLC and an ECOG performance status < or = 2, were enrolled. Treatment consisted of docetaxel 60 mg/m2 and carboplatin AUC 6 every 21 days. Therapy continued for 1 year or 6 months beyond best response, whichever was greater. RESULTS: Twenty-five patients were enrolled. Most patients (80%) had Stage IV disease. The partial response rate was 16%. Response duration ranged from 6 to 115 weeks. Median survival was 55 weeks. Toxicity was generally limited to grade 3 or 4 neutropenia. There was 1 septic death. CONCLUSION: Survival compared favorably to other similar trials employing higher doses of docetaxel. Additionally, a hematologic toxicity advantage was seen compared to regimens containing higher doses of docetaxel.
Aged↗