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  • 1
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    Comparison of the quality of life of early and advanced stage ovarian cancer survivors
    American Society of Clinical Oncology (ASCO) ; 2008
    In:  Journal of Clinical Oncology Vol. 26, No. 15_suppl ( 2008-05-20), p. 5528-5528
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 26, No. 15_suppl ( 2008-05-20), p. 5528-5528
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2008.26.15_suppl.5528
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2008
    detail.hit.zdb_id: 2005181-5
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  • 2
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    A phase II trial of voreloxin in women with platinum-resistant ovarian cancer
    American Society of Clinical Oncology (ASCO) ; 2009
    In:  Journal of Clinical Oncology Vol. 27, No. 15_suppl ( 2009-05-20), p. 5559-5559
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 27, No. 15_suppl ( 2009-05-20), p. 5559-5559
    Abstract: 5559 Background: Voreloxin is a naphthyridine analog that intercalates DNA and inhibits topoisomerase II, inducing apoptosis. Clinical activity has been observed in ovarian cancer and AML. Results are reported from a fully enrolled phase II study of 3 dose levels of single agent voreloxin in patients (pts) with 1° or 2° platinum-resistant or refractory ovarian cancer. Methods: Pts may have received ≤ 3 prior platinum regimens plus one additional non-platinum regimen. PS of 0–1 was required. Voreloxin regimens: Cohort A 48 mg/m 2 q3weeks (wk) (N = 65), Cohort B 60 mg/m 2 q4wk (N = 35), and Cohort C 75 mg/m 2 q4wk (N = 35) by short IV infusion. BRCA status is reported by pt consent. Results: Cohort A: 2CRs, 5PRs; ORR 11%; median PFS 82 days (52–98 days 95%CI); Cohort B: 1CR, 3PRs; ORR 11%, median PFS too early to evaluate (TETE); Cohort C - TETE. Cohort A: Febrile neutropenia (FN) incidence was low (8%). Other common G3 or G4 AEs reported (≥ 5%) were fatigue (14%) and nausea (5%). Dose delays or reductions (40%) occurred typically at Cycle 1, largely due to neutropenia. Cohort B: Dose was increased to 60 mg/m 2 and dosing interval was lengthened to 4 wk, maintaining dose intensity (DI) and allowing adequate time for marrow recovery. ANC dosing criterion was changed from ANC ≥ 1,500 to ≥ 1,000. There was a marked decrease in dose delays and reductions (14%) with only 3% incidence of FN. Common G3 or 4 AEs reported (≥ 5%) were fatigue (11%) and nausea (5%). The safety profile supported further dose escalation to 75 mg/m 2 q4wk (Cohort C- DI increased by 25%). Data are TETE. Conclusions: Preliminary data suggest Cohorts A and B have similar safety and efficacy profiles as anticipated based on comparable DI. Fewer dose reductions and delays occurred in Cohort B, due to revised dosing criteria and increased cycle length to 4 wk. Accrual to Cohort C is complete. Efficacy and safety data for all cohorts will be reported. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2009.27.15_suppl.5559
    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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  • 3
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    Reversion and non-reversion mechanisms of resistance (MoR) to PARP inhibitor (PARPi) or platinum chemotherapy (chemotx) in patients (pts) with BRCA1/2 -mutant metastatic breast cancer (MBC).
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. 1085-1085
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. 1085-1085
    Abstract: 1085 Background: Little is known about MoR to PARPi and platinum chemotx in MBC pts with BRCA1/2 mutations. Biomarkers predictive of response/resistance have not been identified, but could have clinical utility. Methods: We obtained 8 BRCA-mutant metastatic tumor biopsies from MBC pts with acquired resistance to DNA-damaging tx (PARPi/platinum) on a prospective tissue collection protocol. In 7/8 patients, we also obtained pre-tx biopsies. Whole exome sequencing (WES) was performed on each tumor and on germline DNA from blood. We performed immunohistochemical (IHC) staining for RAD51 foci for functional assessment of intact homologous recombination (HR). Results: 4/7 pts with complete WES analysis acquired a somatic reversion mutation likely to result in functional BRCA1/2 protein in the post-tx tumor specimen after platinum (2 pts) or PARPi (2 pts; Table). 4/7 pts had plausible non-reversion MoR identified by WES, including alterations in genes involved in replication fork protection and DNA end resection. As expected, in all pts with genomic reversion, RAD51 foci were acquired in the post-resistance tumor, consistent with reconstitution of HR. In 2 pts without reversion, presence of RAD51 foci post-resistance was mixed. Reversion mutations occurred both with and without other alterations that could possibly lead to fork protection, suggesting 〉 1 MoR could occur in the same tumor. 3 pts whose tumors demonstrated RAD51 foci post-resistance were later re-exposed to DNA-damaging tx, to which all had intrinsic resistance. Conclusions: BRCA1/2 reversion was identified as a MoR in the majority of pts. WES identified potential novel MoR in fork protection and end resection genes. The presence of RAD51 foci by IHC was consistent with BRCA protein functional status from genomic data and predicted response to later DNA-damaging tx, suggesting RAD51 IHC may be a clinically useful biomarker. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.1085
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 4
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    Integrated report of the phase 2 experience with XL999 administered IV to patients (pts) with NSCLC, renal cell CA (RCC), metastatic colorectal CA (CRC), recurrent ovarian CA, acute myelogenous leaukemia (AML), and multiple myeloma (MM)
    American Society of Clinical Oncology (ASCO) ; 2007
    In:  Journal of Clinical Oncology Vol. 25, No. 18_suppl ( 2007-06-20), p. 3591-3591
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 18_suppl ( 2007-06-20), p. 3591-3591
    Abstract: 3591 Background: XL999 is a potent spectrum-selective inhibitor of tyrosine kinases including VEGFR2/KDR, FGFR1/3, PDGFR-β, FLT3, RET, KIT, & SRC. A Ph 1 study in pts w/advanced malignancies has shown anti-tumor activity (3 PRs & 10 SD lasting 3–26 + months) DLTs were cardiac failure & transaminase elevation. Methods: XL999 is being investigated in 6 Ph 2 trials. Pts w/histologically confirmed NSCLC, RCC, CRC, recurrent ovarian CA, AML, & MM were enrolled. The primary objectives of these independent studies are to determine response rate and further evaluate safety and tolerability of XL999. The secondary objectives are to assess PFS, duration of response & OS. Pts receive a once wkly 4hr IV administration of XL999 (2.4 mg/kg). Tumor response is assessed every 8 wks. Results: A total of 79 pts were treated. A confirmed PR was reported in 1/ 9 pts w/NSCLC. An additional 2 pts have SD at 2 & 3 months w/1 showing tumor shrinkage (24%). Two of 11 pts w/RCC have SD at 2 & 4 months. Of 14 pts enrolled w/AML, 1 of 3 with an activating FLT3 mutation had a PR, and 8 of 10 w/circulating myeloblasts had 〉 50% reduction in myeloblasts. AEs = Grade 2 in =10% of pts related to XL999 included N/V, constipation, diarrhea, dry mouth, oral hypoesthesia, fatigue, pyrexia, dizziness, dysguesia, & hypertension. Cardiovascular (CV) events considered SAEs were reported in 11 pts (14%), and all but 1 occurred with the 1st dose of XL999.These events were characterized by ST /T wave changes in ECG,LVEF decreases and /or troponin elevation. Most pts with CV SAEs recovered to baseline within 2–3 wks upon withdrawl of further XL999. Conclusions: XL999 administered IV at a dose of 2.4mg/kg wkly was associated w/CV AEs, the majority of which were associated w/the 1st dose and were generally reversible upon XL999 discontinuation. XL999 shows preliminary evidence of anti- tumor activity in pts w/NSCLC & AML. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2007.25.18_suppl.3591
    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
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    Pharmacokinetic analysis of an all intraperitoneal carboplatin and paclitaxel regimen in ovarian cancer patients demonstrates favorable systemic bioavailability of both agents
    American Society of Clinical Oncology (ASCO) ; 2006
    In:  Journal of Clinical Oncology Vol. 24, No. 18_suppl ( 2006-06-20), p. 5008-5008
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 18_suppl ( 2006-06-20), p. 5008-5008
    Abstract: 5008 Background: A phase III trial (GOG172) demonstrated improved survival for patients with newly diagnosed and optimally debulked ovarian cancer treated with intraperitoneal (ip) cisplatin and paclitaxel (P), given both as a 24 h iv infusion and ip, as compared with standard iv dosing. Studies to further enhance efficacy and minimize toxicity of ip taxane/platinum regimens are needed. Because adequate systemic drug exposure is thought to be essential for maximum therapeutic benefit of ip chemotherapy, the pharmacokinetics (PK) and bioavailability of ip P and carboplatin (C) were determined in this pt population in a phase II trial to evaluate dosing by the ip route alone. Methods: P 60 mg/m 2 once a week and C at an AUC 6 every weeks were infused over 1 h, iv in cycle 1 and ip in the 5 subsequent 21-day cycles. Plasma samples were collected during week 1 of cycles 1, 2 and 6. P was measured by LC/MS and free platinum (fPt) was determined by flameless atomic absorption. Results: PK data is available for 14 pts receiving at least 1 cycle of ip therapy and for 7 pts who received all 5 cycles. When given ip, P achieved a peak conc. in plasma (C max ) of 0.086 ± 0.034 μM (mean ± SD) at 6.4 ± 2.2 h, 22-times lower than C max for iv infusion (1.92 ± 0.80 μM). Thereafter, P plasma levels were comparable for both routes and decayed at similar rates with a half-life of 13.9 ± 4.1 h for iv and 13.7 ± 2.2 h for ip dosing. The systemic bioavailability of ip P was 53 ± 19% for the initial dose and 46 ± 10% in cycle 6. P plasma levels exceeded 0.05 μM, the pharmacologic threshold conc., for 〉 20 h upon ip dosing in 67% (10/15) and 71% (5/7) of pts in cycles 2 and 6, respectively. C was rapidly absorbed into systemic circulation when given ip with a C max of 83 ± 11 μM for fPt at 1.6 ± 0.2 h in cycle 2. Consistent with prior reports, systemic availability of fPt exceeded 100% (133 ± 22% in cycle 2; 142 ± 47% in cycle 6). Conclusions: Weekly ip P 60 mg/m 2 with ip C (AUC 6) every 3 weeks achieved a potentially effective pattern of systemic exposure to both agents in a majority of pts. The cumulative time that P plasma levels are 〉 0.05 μM per cycle of therapy is likely to be longer than provided by the iv/ip dosing regimen for P (135 mg/m 2 24 h iv infusion day 1; 60 mg/m 2 ip day 8) used in GOG172. 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.5008
    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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  • 6
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    Phase II study of carboplatin, paclitaxel and bevacizumab as first line chemotherapy and consolidation for advanced müllerian tumors
    American Society of Clinical Oncology (ASCO) ; 2006
    In:  Journal of Clinical Oncology Vol. 24, No. 18_suppl ( 2006-06-20), p. 5020-5020
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 18_suppl ( 2006-06-20), p. 5020-5020
    Abstract: 5020 Background: Vascular endothelial growth factor (VEGF) is a major promoter of tumor angiogenesis. Bevacizumab is a recombinant humanized monoclonal antibody that neutralizes VEGF and is active in several tumor types, including epithelial ovarian cancer. Methods: We are conducting a phase II trial of carboplatin, paclitaxel and bevacizumab (CPB) in newly diagnosed patients with chemotherapy naïve, stage ≥ IC, epithelial ovarian, fallopian, primary peritoneal, or uterine papillary serous (UPSC) tumors. Patients receive carboplatin AUC of 5 IV, paclitaxel 175 mg/m 2 IV, and bevacizumab 15 mg/kg IV for 6–8 cycles on a 21-day cycle. Bevacizumab is omitted in the first cycle, and continued for one year’s consolidation. Principle endpoints include response rate and progression free survival. Results: Since 3/05, 35 patients have been enrolled. Of the 30 evaluable patients, 24 have ovarian, 4 peritoneal, 1 fallopian tube cancer, and 1 UPSC (1 stage IIB, 22 stage III, and 7 stage IV), and median age is 57 (range 18–77). 133 cycles of chemotherapy have been administered with acceptable toxicity. Grade IV neutropenia has been seen in 3 cycles with 1 episode of febrile neutropenia. Grade I, II, and III HTN was observed in 1, 3, and 4 cycles, and grade I (42% hematuria 45% epistaxis) and II bleeding observed in 36 and 1 cycle(s), respectively. There has been 1 nasal perforation, 2 delayed wound healing, and no bowel perforation. 1 woman withdrew consent (for PMH diverticulitis), and 3 women have been removed for toxicity (1 autonomic neurotoxicity, 1 HTN, and 1 PE). To date, 13 patients have completed the chemotherapy phase of treatment, and only one patient has come off study for progression on consolidation bevacizumab. Conclusion: First line CBP is a highly active regimen that has been well tolerated thus far. Updated toxicity and response data will be available in the spring of 2006. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2006.24.18_suppl.5020
    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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  • 7
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    Clinical activity of pertuzumab (rhuMab 2C4) in advanced, refractory or recurrent ovarian cancer (OC), and the role of HER2 activation status
    American Society of Clinical Oncology (ASCO) ; 2005
    In:  Journal of Clinical Oncology Vol. 23, No. 16_suppl ( 2005-06), p. 5051-5051
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 23, No. 16_suppl ( 2005-06), p. 5051-5051
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2005.23.16_suppl.5051
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2005
    detail.hit.zdb_id: 2005181-5
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  • 8
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    Long-acting octreotide for the treatment of symptoms of bowel obstruction in advanced ovarian cancer
    American Society of Clinical Oncology (ASCO) ; 2005
    In:  Journal of Clinical Oncology Vol. 23, No. 16_suppl ( 2005-06), p. 5159-5159
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 23, No. 16_suppl ( 2005-06), p. 5159-5159
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2005.23.16_suppl.5159
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2005
    detail.hit.zdb_id: 2005181-5
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  • 9
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    PROFILE: Broadly based genomic testing for all patients at a major cancer center.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 1531-1531
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 1531-1531
    Abstract: 1531 Background: Genotyping plays an increasingly important role in the management of cancer patients. However, the landscape of genomic abnormalities is unknown for many cancers and the influence of specific genotypes on clinical behavior is often unclear. To address these deficiencies, we developed PROFILE, a project designed to obtain genomic information on all patients who come to our hospitals for cancer-related care. Methods: Clinically acquired specimens were genotyped using a mass spectrometry genotyping test (OncoMap) which assays 471 alleles in 41 cancer-related genes. Because the majority of these alleles currently have no known clinical meaning, we implemented PROFILE as a research test. This required developing an "umbrella" protocol governing PROFILE activity, a highly simplified 2-page consenting brochure, and a centralized consenting process. We created process flows for retrieving clinical specimens and performing OncoMap in a CLIA-certified laboratory. We return results on individual participants to their ordering providers who can use actionable findings to guide management. All results are stored in a database which can be queried using a web-based search tool that returns aggregate results. Approval to link specimen to clinical information can be sought by a streamlined process of User Committee and IRB approval, and linkage is performed by IS acting as honest brokers. Results: From August 2011 through December 2012, we consented 12,980 patients (consent rate 〉 70%). We found that 39% of clinical samples are of sufficient quality to yield OncoMap results. We have reported and stored 3,000 genotyping results. OncoMap mutations were detected in 40% of clinical samples. As expected, mutations in KRAS, PIK3CA, TP53, and BRAF were most commonly observed across all tumor types. However, rarer mutations were also detected in RET, PIK3R1, and ERBB2 among others. Conclusions: Novel operational approaches have permitted enterprise-wide, broadly-based genotyping that serves a combination of research and clinical needs. Early insights from this database will be discussed along with information about their impact on clinical management.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.1531
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 10
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    Online Resource
    ErbB3 protein expression in serous ovarian carcinomas of elderly women
    American Society of Clinical Oncology (ASCO) ; 2007
    In:  Journal of Clinical Oncology Vol. 25, No. 18_suppl ( 2007-06-20), p. 16026-16026
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 18_suppl ( 2007-06-20), p. 16026-16026
    Abstract: 16026 Background: Ovarian carcinoma is the leading cause of death due to gynecologic malignancies, and older age at the time of diagnosis has been suggested to correlate with poorer outcome. Recent studies suggest that expression of ErbB3, a member of the epidermal growth factor receptor family, is associated with decreased survival. The goal of this study was to examine ErbB3 protein expression with a tissue microarray (TMA) comprised of advanced papillary serous (PS) ovarian carcinomas, and to correlate results with clinical information to evaluate for expression differences in younger and older women. Methods: A high density TMA (with 4 cores per primary tumor) was constructed by retrospective review of PS ovarian carcinoma cases seen between 1999 and 2005. Patients were divided into 2 cohorts based on age (=65 and =55 at diagnosis). Only cases of stage III or IV disease were included, and patients with BRCA mutations were excluded. Clinical data were obtained by chart and database review. TMA sections were immunostained for ErbB3, and expression was correlated with age, stage, and overall survival. Results: 136 primary tumors were available: 72 in the =65 group, 64 in the =55 group. Tumors from the =65 cohort were significantly less likely to express ErbB3 (16.7%) when compared to the ≤55 cohort (51.6%) (p 〈 0.0001). Patients whose tumors expressed ErbB3 had decreased median survival (33.6 months) compared to ErbB3 negative cases (47.3 months), but these results were not statistically significant (p=0.10). ErbB3 expression correlated in a borderline significant manner with stage (dichotomized as IIIa/IIIb vs. IIIc/IV) at the time of diagnosis (stage IIIa/b 11.8%+ vs. stage IIIc/IV 36.1%+; p=0.055). Multivariate analysis with respect to age, stage, and ErbB3 status did not reveal ErbB3 to be a statistically significant predictor of poor outcome in this data set. Conclusions: These results demonstrate that PS ovarian carcinomas in patients aged =65 at the time of diagnosis are significantly less likely to express ErbB3 than those ≤55. Correlation between ErbB3 expression and more advanced stage at the time of diagnosis bordered on significance. There was a non-significant trend towards decreased overall survival in both univariate and multivariate analyses in patients whose tumors exhibited ErbB3 expression. 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.16026
    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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