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  • American Society of Clinical Oncology (ASCO)  (6)
  • 2005-2009  (6)
  • 1
    Online Resource
    Online Resource
    Long-term impact of chemotherapy on early stage ovarian cancer patients
    American Society of Clinical Oncology (ASCO) ; 2006
    In:  Journal of Clinical Oncology Vol. 24, No. 18_suppl ( 2006-06-20), p. 5024-5024
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 18_suppl ( 2006-06-20), p. 5024-5024
    Abstract: 5024 Background: Quality of life (QOL) assessments in early stage (stage I and II) ovarian cancer survivors (CS) are limited and have to date not focused on CS who have received adjuvant platinum- and taxane-based chemotherapy (CT). Methods: 55 early stage ovarian patients (pts) were identified from patient logs from the Dana-Farber Cancer Institute and Massachusetts General Hospital. 54 pts. received CT. QOL and long-term medical sequelae were measured in pts who were 〉 3 years from diagnosis and had no evidence of recurrent cancer. Pts were interviewed by phone, and the following surveys were administered: EORTC QLQ-C30 (EORTC) and QLQ-OV28 (OV-28), MHI-17, CALGB sexual functioning, GOG Neuropathy, FACT Fatigue, Beck’s Hopelessness, Fear of Recurrence (FOR), Dyadic Adjustment Scale (DAS), PCL-C post-traumatic stress disorder (PTSD), Unmet Needs, FACT-Spirituality (FACT-Sp), complementary therapy use, and MOS Social Support (MOS). Results: 55 pts were interviewed (mean age 58 yrs, range 34 to 77 yrs). Mean time between diagnosis and interview was 5.6 yrs. CS reported significantly higher MHI-17 scores than the population norm, and higher MHI-17 scores were associated with better overall QOL (EORTC, r = 0.57, p 〈 0.0001), increased social support (MOS, r = 0.54, p 〈 0.0001), and better marital relationships (DAS, r = 0.42, p 〈 0.001). Sexual problems (1.57 out of 6) and unmet needs (1.5 out of 14) were minimal. FOR was correlated with lowered overall QOL (EORTC, r = −0.63, p 〈 0.0001), increased abdominal symptoms (OV-28 abdominal scale, r = 0.48, p 〈 0.0002), increased hopelessness (Beck’s, r = 0.46, p 〈 0.0005), and increased spirituality (FACT-Sp, r = −0.57, p 〈 0.0001). CS were using 5.4 complementary therapies for QOL purposes and 5.8 for cancer treatment. Minimal negative socioeconomic impact was observed in CS (0.16 out of 4). However, 12.5% of pts had scores indicative of a diagnosis of PTSD. Conclusions: Long-term QOL follow-up of early stage ovarian cancer survivors demonstrated minimal long-term symptoms, excellent mental health, minimal unmet needs, and minimal socioeconomic impact. No significant financial relationships to disclose.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2006.24.18_suppl.5024
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2006
    detail.hit.zdb_id: 2005181-5
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Increased Toxicity With Gefitinib, Capecitabine, and Radiation Therapy in Pancreatic and Rectal Cancer: Phase I Trial Results
    American Society of Clinical Oncology (ASCO) ; 2006
    In:  Journal of Clinical Oncology Vol. 24, No. 4 ( 2006-02-01), p. 656-662
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 4 ( 2006-02-01), p. 656-662
    Abstract: Overexpression of epidermal growth factor receptor (EGFR) has been associated with aggressive tumor phenotypes, chemotherapy, and radiation resistance, as well as poor survival in preclinical and clinical models. The EGFR inhibitor gefitinib potentiates chemotherapy and radiation tumor cytotoxicity in preclinical models, including pancreatic and colorectal cancer. We initiated two phase I trials assessing the combination of gefitinib, capecitabine, and radiation in patients with localized pancreatic and rectal cancer. Patients and Methods Patients with pathologically confirmed adenocarcinoma of the pancreas and rectum were eligible. Pretreatment staging included computed tomography, endoscopic ultrasound, and surgical evaluation. Patients received 50.4 Gy of external-beam radiation therapy to the tumor in 28 fractions. Capecitabine and gefitinib were administered throughout the radiation course. Following completion, patients were restaged and considered for resection. Primary end points included determination of dose-limiting toxicity (DLT) and a phase II dose; secondary end points included determination of non-DLTs and preliminary radiographic and pathologic response rates. Results Ten patients were entered in the pancreatic study and six in the rectal study. DLT was seen in six of 10 patients in the pancreatic study and two of six patients in the rectal study. The primary DLT in both studies was diarrhea. Two patients developed arterial thrombi. Conclusion The combination of gefitinib, capecitabine, and radiation in pancreatic and rectal cancer patients resulted in significant toxicity. A recommended phase II dose was not determined in either of our studies. Further investigation with this combination should be approached with caution.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2005.04.1749
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2006
    detail.hit.zdb_id: 2005181-5
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  • 3
    Online Resource
    Online Resource
    Sorafenib With Interferon Alfa-2b As First-Line Treatment of Advanced Renal Carcinoma: A Phase II Study of the Southwest Oncology Group
    American Society of Clinical Oncology (ASCO) ; 2007
    In:  Journal of Clinical Oncology Vol. 25, No. 22 ( 2007-08-01), p. 3296-3301
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 22 ( 2007-08-01), p. 3296-3301
    Abstract: This phase II study evaluated the activity of combined treatment with interferon alfa-2b and sorafenib, a Raf and multiple receptor tyrosine kinase inhibitor, in patients with advanced renal carcinoma. Patients and Methods Eligible patients had metastatic or unresectable renal carcinoma with a clear-cell component, no prior systemic therapy, performance status 0 to 1, and measurable disease. Treatment consisted of interferon alfa-2b 10 × 10 6 U subcutaneously three times weekly and sorafenib 400 mg orally bid. The primary end point was confirmed Response Evaluation Criteria in Solid Tumors response rate. Results Twelve (19%) of 62 assessable patients achieved an objective confirmed response. An additional 31 (50%) had an unconfirmed partial response or stable disease as best response. The median progression-free survival was 7 months (95% CI, 4 to 11 months). The most common adverse events were fatigue, anorexia, anemia, diarrhea, nausea, rigors/chills, leukopenia, fever, and transaminase elevation. Von Hippel-Lindau gene mutations were detected in four (22%) of 18 archival tumor specimens. Conclusion The confirmed response rate for the combination of sorafenib and interferon in advanced renal carcinoma is greater than expected with either interferon or sorafenib alone. The toxicity of this combination is dominated by adverse events common to interferon that limit further development of this regimen.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2007.11.1047
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2007
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks
    American Society of Clinical Oncology (ASCO) ; 2007
    In:  Journal of Clinical Oncology Vol. 25, No. 32 ( 2007-11-10), p. 5051-5057
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 32 ( 2007-11-10), p. 5051-5057
    Abstract: The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2007.11.3324
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2007
    detail.hit.zdb_id: 2005181-5
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  • 5
    Online Resource
    Online Resource
    Triple Receptor–Negative Breast Cancer: The Effect of Race on Response to Primary Systemic Treatment and Survival Outcomes
    American Society of Clinical Oncology (ASCO) ; 2009
    In:  Journal of Clinical Oncology Vol. 27, No. 2 ( 2009-01-10), p. 220-226
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 27, No. 2 ( 2009-01-10), p. 220-226
    Abstract: The goal of this study was to describe the effect of race on pathologic complete response (pCR) rates and survival outcomes in women with triple receptor–negative (TN) breast cancers. Patients and Methods Four hundred seventy-one patients with TN breast cancer diagnosed between 1996 and 2005 and treated with primary systemic chemotherapy were included. pCR was defined as no residual invasive cancer in the breast and axillary lymph nodes. Overall survival (OS) and recurrence-free survival (RFS) were estimated using the Kaplan-Meier product-limit method and compared between groups using the log-rank test. Cox proportional hazards models were fitted for each survival outcome to determine the relationship of patient and tumor variables with outcome. Results Median follow-up time was 24.5 months. One hundred patients (21.2%) were black, and 371 patients (78.8%) were white/other race. Seventeen percent of black patients (n = 17) and 25.1% of white/other patients (n = 93) achieved a pCR (P = .091). Three-year RFS rates were 68% (95% CI, 56% to 76%) and 62% (95% CI, 57% to 67%) for black and white/other patients, respectively, with no significant difference observed between the two groups (P = .302). Three-year OS was similar for the two racial groups. After controlling for patient and tumor characteristics, race was not significantly associated with RFS (hazard ratio [HR] = 1.08; 95% CI, 0.69 to 1.68; P = .747) or OS (HR = 1.08; 95% CI, 0.69 to 1.68; P = .735) when white/other patients were compared with black patients. Conclusion Race does not significantly affect pCR rates or survival outcomes in women with TN breast cancer treated in a single institution under the same treatment conditions.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2008.17.9952
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2009
    detail.hit.zdb_id: 2005181-5
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  • 6
    Online Resource
    Online Resource
    Entering a Clinical Trial: Is It Right For You? –A randomized study of the Clinical Trials Video and its impact on the informed consent process
    American Society of Clinical Oncology (ASCO) ; 2007
    In:  Journal of Clinical Oncology Vol. 25, No. 18_suppl ( 2007-06-20), p. 9072-9072
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 18_suppl ( 2007-06-20), p. 9072-9072
    Abstract: 9072 Background: In an effort to improve the informed consent process for subjects considering participation in a clinical trial, we created an educational video: “Entering a Clinical Trial: Is it Right for You?” In this randomized study, we assessed the effect of the video on patients’ understanding and perceptions of clinical trials. We also assessed patient satisfaction with the video and how the video impacted decision-making and patient-provider communication. Methods: We recruited 90 adults considering cancer clinical trials of whom 77 participated. After discussing the trial with the physician and reading the trial consent form, patients were randomized to receive (n=38) or not receive (n=39) the study video. Using a validated questionnaire, we interviewed subjects to assess objective understanding of the trial, our primary endpoint, and self-reported understanding of clinical trials. All subjects completed a second interview assessing secondary endpoints, including patient-provider communication, satisfaction with video, and decision-making. We used linear regression (two-sided tests) to conduct the primary analysis and the Wilcoxon rank-sum test and descriptive statistics to analyze the secondary aims. Results: Neither objective nor self-reported understanding of clinical trials differed between the two groups (Mean 86.5 vs. 87, p=0.75). 85% (61/72) indicated the video was an important source of information about clinical trials; 89% of those who watched the video with their family/friends (n=37) said the video helped loved ones better understand clinical trials; 73% indicated it helped their family accept their decision about participation. 81% (58/72) felt better prepared to discuss the trial with their physician after watching the video. Of those who found the video helpful with decision- making, 80% (21/26) were considering a trial for the first time compared with 19% (5/26) veterans who had previously participated in a clinical trial. Conclusions: The video did not measurably improve subjects’ understanding of their clinical trials. However, subjects reported that the video was an important source of information, helped them educate their families, and enhanced patient-provider communication. No significant financial relationships to disclose.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2007.25.18_suppl.9072
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2007
    detail.hit.zdb_id: 2005181-5
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