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  • American Society of Clinical Oncology (ASCO)  (29)
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  • 1
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2004
    In:  Journal of Clinical Oncology Vol. 22, No. 14_suppl ( 2004-07-15), p. 4024-4024
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 22, No. 14_suppl ( 2004-07-15), p. 4024-4024
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2004
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2004
    In:  Journal of Clinical Oncology Vol. 22, No. 14_suppl ( 2004-07-15), p. 4024-4024
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 22, No. 14_suppl ( 2004-07-15), p. 4024-4024
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2004
    detail.hit.zdb_id: 2005181-5
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  • 3
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2006
    In:  Journal of Clinical Oncology Vol. 24, No. 18_suppl ( 2006-06-20), p. 17002-17002
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 18_suppl ( 2006-06-20), p. 17002-17002
    Abstract: 17002 Background: A current option for recurrent NSCLC is monotherapy with docetaxel. However, cisplatin, if tolerable, may still have power for this condition. Irinotecan is also a key drug for NSCLC. The objectives of this study were to evaluate the clinical relevance of weekly chemotherapy consisting of irinotecan and cisplatin as a 2nd-line therapy for NSCLC. Methods: Patients meeting all following criteria were eligible: proven NSCLC refractory or recurrent after previous single-regimen chemotherapy, PS (0–2), age 〉 15 years, adequate organ functions, measurable lesions by RECIST, life expectancy exceeding 8 weeks, and written informed consent. Patients with any of the following conditions were ineligible: previous treatment with irinotecan and/or surgery, requirement of thoracic irradiation, interstitial lung disease, pleural effusion or ascites requiring treatment, pericardial effusion, symptomatic brain metastasis, concomitant malignancy or other inadequate condition. Irinotecan (60 mg/m 2 in 500 ml electrolyte soln, day 1) and cisplatin (25 mg/m 2 in 500 ml saline, day 1, without further hydration) were administered every week for at least 6 courses unless encountering defined skip criteria. Calculated minimum sample size was 43 based on Simon two-stage optimal design with p0=0.10, p1=0.25, α error=0.05 and β error=0.20; planned sample size was 48. The primary endpoint was response rate, and the secondary ones were toxicity and survival time. Results: Since February 2002, 48 patients (consisting of 29 with adeno-, 14 with squamous cell, 3 with large cell carcinoma and 2 with NSCLC not further specified) with a median age of 62-years were enrolled, with 1 death before treatment. Therefore, 47 patients were eligible for evaluation of response rate and toxicity, whereas all 48 were analyzed for survival. Chemotherapy was administered for a median 6 courses (range, 0–15). Response rate was 25.5% (95% CI: 12.9–38.1%). Toxicity of grade 3 or 4 consisted of neutropenia (29.8%), thrombocytopenia (6.4%), anemia (29.8%), diarrhea (10.6%) and nausea (21.3%). MST was 10.6 months, and 1-year survival rate was 43%. Conclusions: This 2nd-line chemotherapy for NSCLC showed promising efficacy with tolerable toxicity. No significant financial relationships to disclose.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2006
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2009
    In:  Journal of Clinical Oncology Vol. 27, No. 15_suppl ( 2009-05-20), p. e17042-e17042
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 27, No. 15_suppl ( 2009-05-20), p. e17042-e17042
    Abstract: e17042 Background: The aim of this study is to clarify the clinical profile of proton beam therapy for mucosal melanoma of the head and neck. Methods: Patients with mucosal melanoma of the head and neck fulfilling the following criteria were enrolled: histologically confirmed malignant melanoma; N0 and M0 disease. Proton therapy was delivered three times a week with planned total dose of 60 GyE in 15 fractions. Results: From January 2004 through January 2007, thirteen patients were enrolled in this study. Patients’ characteristics were as follows: median age, 75 years (range, 56 to 79); male/female, 7/6; T1/2/3/4/rec, 3/2/0/7/1. All could receive the full dose of proton therapy. The most common acute toxicities were mucositis (grade 3: 15%) and dermatitis (grade 2: 15%). One patient had unilateral impairment of visual acuity possibly related with treatment. Initial local control rate was 77.0% (10/13, 95%CI: 46.2–95.0%). With median follow up period of 33.7 months, median progression free survival was 18.9 months and median survival time was not reached. 2-year overall survival rate was 69.7% (95%CI: 31.6–86.1%). Most frequent site of first failure was cervical lymph nodes outside of PTV. Four patients died of disease; cachexia caused by distant metastases in three and carotid blowout because of nodal disease in one. Conclusions: Proton beam therapy for mucosal melanoma of the head and neck achieved favorable results in this limited number of patients, although further investigation about late toxicity is needed. Now, the phase II study of this treatment is ongoing. No significant financial relationships to disclose.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2009
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 29, No. 15_suppl ( 2011-05-20), p. 9507-9507
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2011
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  • 6
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2010
    In:  Journal of Clinical Oncology Vol. 28, No. 15_suppl ( 2010-05-20), p. e16003-e16003
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 28, No. 15_suppl ( 2010-05-20), p. e16003-e16003
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2010
    detail.hit.zdb_id: 2005181-5
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  • 7
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2004
    In:  Journal of Clinical Oncology Vol. 22, No. 14_suppl ( 2004-07-15), p. 4220-4220
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 22, No. 14_suppl ( 2004-07-15), p. 4220-4220
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2004
    detail.hit.zdb_id: 2005181-5
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  • 8
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 7061-7061
    Abstract: 7061 Background: MMB, an oral JAK1/2 and ACVR1/ALK2 inhibitor, showed clinical activity on MF symptoms, RBC transfusion requirements (anemia), and spleen volume in the SIMPLIFY trials, including in MF patients (pts) with thrombocytopenia. MOMENTUM is a pivotal phase 3 study of symptomatic and anemic MF pts previously treated with a JAK inhibitor (JAKi) testing MMB vs DAN. This analysis evaluated MOMENTUM pts with baseline (BL) platelet counts (PLT) ≤150 x 10 9 /L. Methods: Eligibility: Primary or post-ET/PV MF; DIPSS high risk, Int-2, or Int-1; MF Symptom Assessment Form Total Symptom Score (MFSAF TSS) ≥10; Hgb 〈 10 g/dL; prior JAKi for ≥90 days, or ≥28 days if RBC transfusions ≥4 units in 8 weeks (wks) or Gr 3/4 thrombocytopenia, anemia, or hematoma; palpable spleen ≥5 cm; PLT ≥25 x 10 9 /L. JAKi taper and washout was ≥21 days. Randomization: 2:1 to MMB 200 mg QD plus DAN placebo or DAN 600 mg QD plus MMB placebo for 24 wks. Primary endpoint: TSS response (≥50% reduction from BL) rate at wk 24. Key secondary endpoints, assessed sequentially at wk 24: RBC transfusion independence (TI) rate, splenic response rate (SRR; ≥25% reduction in volume from BL), change from BL in TSS, SRR (≥35% reduction from BL) and rate of zero transfusions since BL. Results: 60 (74%) of 81 MMB pts and 25 (58%) of 43 DAN pts with BL PLT ≤150 x 10 9 /L completed the 24-week randomized treatment (RT) phase. Median BL TSS were 29 (MMB) and 24 (DAN), Hgb were 7.9 (MMB) and 8.0 (DAN) g/dL, and PLT were 67 x 10 9 /L (MMB) and 64 x 10 9 /L (DAN). Prior JAKi was ruxolitinib in 124 pts (100%) and fedratinib in 6 pts (5%). Efficacy results are in Table. These results are consistent with the overall ITT analysis set (N=195). Most common Gr ≥3 TEAEs in the RT phase were thrombocytopenia (MMB, 31%; DAN, 16%) and anemia (MMB, 7%; DAN, 14%); Gr ≥3 bleeding events occurred in 9% of MMB and 5% of DAN pts. TEAEs led to study drug discontinuation in 15% of MMB and 19% of DAN pts in RT phase. A trend toward improved OS up to wk 24 was seen with MMB vs DAN [HR (95% CI)=0.490 (0.195, 1.235)]. Additional analyses of pts with BL PLT 〈 100 x 10 9 /L (N=100) and BL PLT 〈 50 x 10 9 /L (N=31) show similar treatment effects of MMB vs DAN. Conclusions: In thrombocytopenic MF pts who were symptomatic and anemic, MMB was superior to DAN for symptom responses, transfusion requirements, and spleen responses and showed comparable safety and favorable survival. MMB may address a critical unmet need in thrombocytopenic MF pts. Clinical trial information: NCT04173494. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 9
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 7002-7002
    Abstract: 7002 Background: MMB, an oral JAK1/2 and ACVR1/ALK2 inhibitor, showed clinical activity on MF symptoms, RBC transfusion requirements (anemia), and spleen volume in the SIMPLIFY trials. This pivotal phase 3 study of MF patients (pts) previously treated with a JAK inhibitor (JAKi) tested MMB vs DAN on key symptom, anemia, and spleen volume endpoints at 24 weeks (wks). Methods: Eligibility: Primary or post-ET/PV MF; DIPSS high risk, Int-2, or Int-1; MF Symptom Assessment Form Total Symptom Score (MFSAF TSS) ≥10; Hgb 〈 10 g/dL; prior JAKi for ≥90 days, or ≥28 days if RBC transfusions ≥4 units in 8 wks or Gr 3/4 thrombocytopenia, anemia, or hematoma; palpable spleen ≥5 cm. Stratification: TSS, palpable spleen, and RBC units transfused. JAKi taper and washout was ≥21 days. Randomization: 2:1 to MMB 200 mg QD plus DAN placebo or DAN 600 mg QD plus MMB placebo for 24 wks, after which pts could receive open-label MMB. Assessments: Pt reported symptoms using a daily eDiary and spleen volume by MRI or CT. The primary endpoint was TSS response (≥50% reduction from baseline [BL]) rate at wk 24. Secondary endpoints, assessed sequentially at wk 24, were RBC transfusion independence (TI) rate, splenic response rate (SRR; ≥25% reduction in volume from BL), change from BL in TSS, SRR (≥ 35% reduction from BL) and rate of zero transfusions since BL. Results: 94 of 130 (72%) MMB pts and 38 of 65 (58%) DAN pts completed the 24-wk randomized treatment (RT) phase. Median BL TSS were 28 (MMB) and 26 (DAN), Hgb were 8.1 (MMB) and 7.9 (DAN) g/dL, and platelets were 97 (MMB) and 94 (DAN) x10 9 /L. BL TI was 13% (MMB) and 15% (DAN). Prior JAKi was ruxolitinib in 195 pts (100%) and fedratinib in 9 pts (5%). All primary and key secondary endpoints were met (Table). Most common Gr ≥3 TEAEs in the RT phase of the study were thrombocytopenia (MMB, 22%; DAN, 12%) and anemia (MMB, 8%; DAN, 11%). Gr ≥3 infections occurred in 15% of MMB and 17% of DAN pts. Peripheral neuropathy occurred in 5 (4%) of MMB (all Gr ≤2) and 1 (2%) of DAN (Gr ≤2) pts in the RT phase, and none discontinued study drug. Overall, TEAEs led to study drug discontinuation in 18% of MMB and 23% of DAN pts in RT phase. A trend toward improved OS up to wk 24 was seen with MMB vs DAN (HR=0.506, p=0.0719). Conclusions: In symptomatic and anemic MF pts, MMB was superior to DAN for symptom responses, transfusion requirements, and spleen responses with comparable safety and favorable survival. MMB may address a critical unmet need, particularly in MF pts with anemia. Clinical trial information: NCT04173494. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 10
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2006
    In:  Journal of Clinical Oncology Vol. 24, No. 18_suppl ( 2006-06-20), p. 9006-9006
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 18_suppl ( 2006-06-20), p. 9006-9006
    Abstract: 9006 Background: The Childhood Cancer Survivor Study (CCSS) is an NIH funded project (U01-CA 55727) designed to study the effects of childhood cancer treatment on long- term survivors. Previous studies have found associations between certain cancer therapies and visual complications. Methods: The CCSS is a retrospective cohort study investigating health outcomes of long-term survivors ( 〉 5 years) diagnosed and treated between 1970 and 1986 compared to a randomly selected sibling cohort. Questionnaires were completed by 14,362 survivors of childhood cancer and 3,901 sibling controls. Analysis determined the first occurrence of 8 visual conditions in 3 time periods: during therapy, end of therapy to 5 years post diagnosis, and greater than or equal to 5 years post diagnosis. Multivariate analyses, adjusting for current age and gender, determined the relative risks (RR) and 95% confidence interval (CI) of visual conditions by treatment exposure. Results: Survivors had statistically significant increases in the RR of cataracts, glaucoma, legal blindness, double vision, retinal condition, and dry eyes, across all time periods, when compared to siblings. During the time period of 5 or more years post-diagnosis, statistically significant positive associations were present for cataracts and other head radiation, craniospinal radiation, total body radiation, and prednisone; glaucoma and craniospinal radiation; double vision and craniospinal radiation; legally blind and other head radiation and craniospinal radiation; and dry eyes and other head radiation, total body radiation, and dexamethasone. There were no statistically significant associations between treatment factors and retinal conditions. Conclusions: Childhood cancer survivors are at risk of developing visual complications and treatment related factors are important determinants of this risk. Follow-up is needed to evaluate the impact of visual conditions on quality of life. [Table: see text] No significant financial relationships to disclose.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2006
    detail.hit.zdb_id: 2005181-5
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