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  1. Article: New tests for null hypothesis of non unity ratio of proportions.

    Koti, Kallappa M

    Journal of biopharmaceutical statistics

    2007  Volume 17, Issue 2, Page(s) 229–245

    Abstract: Testing for noninferiority and equivalence between an experimental therapy and a standard therapy in terms of the ratio of binomial proportions is considered. New tests based on the Fieller-Hinkley distribution of the ratio of random variables are ... ...

    Abstract Testing for noninferiority and equivalence between an experimental therapy and a standard therapy in terms of the ratio of binomial proportions is considered. New tests based on the Fieller-Hinkley distribution of the ratio of random variables are proposed. Restricted maximum likelihood estimates of the null variances are used to derive the tests. Sample size determination is discussed. The proposed test procedure is extended to multiple tables. The tests are applied to numerical examples.
    MeSH term(s) Confidence Intervals ; Controlled Clinical Trials as Topic/methods ; Controlled Clinical Trials as Topic/standards ; Controlled Clinical Trials as Topic/statistics & numerical data ; Data Interpretation, Statistical ; Humans ; Models, Statistical ; Research Design/standards ; Research Design/statistics & numerical data ; Sample Size
    Language English
    Publishing date 2007
    Publishing country England
    Document type Journal Article
    ZDB-ID 1131763-2
    ISSN 1520-5711 ; 1054-3406
    ISSN (online) 1520-5711
    ISSN 1054-3406
    DOI 10.1080/10543400601177426
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Use of the Fieller-Hinkley distribution of the ratio of random variables in testing for noninferiority.

    Koti, Kallappa M

    Journal of biopharmaceutical statistics

    2007  Volume 17, Issue 2, Page(s) 215–228

    Abstract: We address the noninferiority assessment problem defined in terms of the ratio of population means in a parallel group design analysis of variance setting. The sample ratio as a point estimate of the corresponding population ratio has been considered. It ...

    Abstract We address the noninferiority assessment problem defined in terms of the ratio of population means in a parallel group design analysis of variance setting. The sample ratio as a point estimate of the corresponding population ratio has been considered. It has been shown that the Fieller-Hinkley distribution of the ratio of two correlated normally distributed random variables readily provide a technique for constructing confidence intervals comparable to the bootstrap percentile and Fieller's confidence intervals. A finite parameter space based level alpha test of an inferiority hypothesis formulated in terms of a fixed margin has been derived. We illustrate our approach using the forced vital capacity (FVC) data. We claim that it is easy to construct and straight forward to interpret our bootstrap equivalent confidence intervals that are used to assess noninferiority. We discuss appropriate methods for calculation of sample sizes.
    MeSH term(s) Confidence Intervals ; Controlled Clinical Trials as Topic/methods ; Controlled Clinical Trials as Topic/standards ; Controlled Clinical Trials as Topic/statistics & numerical data ; Data Interpretation, Statistical ; Humans ; Models, Statistical ; Research Design/standards ; Research Design/statistics & numerical data ; Sample Size
    Language English
    Publishing date 2007
    Publishing country England
    Document type Journal Article
    ZDB-ID 1131763-2
    ISSN 1520-5711 ; 1054-3406
    ISSN (online) 1520-5711
    ISSN 1054-3406
    DOI 10.1080/10543400601177335
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Evaluating and adjusting for premature censoring of progression-free survival.

    Rothmann, Mark / Koti, Kallappa / Lee, Kyung Yul / Lu, Hong Laura / Shen, Yuan Li / Zhang, Jenny J / Jin, Mei / Zhou, Haojin

    Journal of biopharmaceutical statistics

    2013  Volume 23, Issue 5, Page(s) 1091–1105

    Abstract: The intent-to-treat principle, grouping subjects as they were randomized and following all subjects to the endpoint or the end of study, allows valid statistical comparisons. Progression-free survival (PFS) has been used as a decision-making endpoint in ... ...

    Abstract The intent-to-treat principle, grouping subjects as they were randomized and following all subjects to the endpoint or the end of study, allows valid statistical comparisons. Progression-free survival (PFS) has been used as a decision-making endpoint in oncology. It can be difficult to have a meaningful intent-to-treat analysis of PFS as some studies have extensive loss to follow-up for PFS. In the analysis, subjects lost to follow-up for PFS have their PFS times censored, with the censoring treated as noninformative. We use remaining overall survival to investigate whether premature censoring for PFS is informative and the potential bias in treating such censoring as noninformative.
    MeSH term(s) Decision Making ; Disease-Free Survival ; Endpoint Determination/methods ; Endpoint Determination/statistics & numerical data ; Humans ; Lost to Follow-Up ; Models, Statistical ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/statistics & numerical data ; Sensitivity and Specificity ; Survival Analysis
    Language English
    Publishing date 2013
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1131763-2
    ISSN 1520-5711 ; 1054-3406
    ISSN (online) 1520-5711
    ISSN 1054-3406
    DOI 10.1080/10543406.2013.813526
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Missing data in biologic oncology products.

    Rothmann, Mark D / Koti, Kallappa / Lee, Kyung Yul / Lu, Hong Laura / Shen, Yuan Li

    Journal of biopharmaceutical statistics

    2009  Volume 19, Issue 6, Page(s) 1074–1084

    Abstract: The intent-to-treat principle requires analyses according to the treatment groups to which patients were randomized and that patients be followed to the occurrence of the endpoint or the end of study. This provides unbiased comparisons with valid p ... ...

    Abstract The intent-to-treat principle requires analyses according to the treatment groups to which patients were randomized and that patients be followed to the occurrence of the endpoint or the end of study. This provides unbiased comparisons with valid p values. For many trials the limitations of the data will not be known until the data are analyzed. In this article, the loss-to-follow-up with respect to the intent-to-treat principle on the most important efficacy endpoints was evaluated for clinical trials of anticancer biologic products submitted to the FDA from August 2005 to October 2008. We provide recommendations in light of the results.
    MeSH term(s) Biological Products/therapeutic use ; Disease-Free Survival ; Endpoint Determination ; Humans ; Intention to Treat Analysis/statistics & numerical data ; Neoplasms/drug therapy ; Neoplasms/mortality
    Chemical Substances Biological Products
    Language English
    Publishing date 2009-11
    Publishing country England
    Document type Journal Article
    ZDB-ID 1131763-2
    ISSN 1520-5711 ; 1054-3406
    ISSN (online) 1520-5711
    ISSN 1054-3406
    DOI 10.1080/10543400903242993
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: U.s. Food and Drug Administration approval: carfilzomib for the treatment of multiple myeloma.

    Herndon, Thomas M / Deisseroth, Albert / Kaminskas, Edvardas / Kane, Robert C / Koti, Kallappa M / Rothmann, Mark D / Habtemariam, Bahru / Bullock, Julie / Bray, Jeffrey D / Hawes, Jessica / Palmby, Todd R / Jee, Josephine / Adams, William / Mahayni, Houda / Brown, Janice / Dorantes, Angelica / Sridhara, Rajeshwari / Farrell, Ann T / Pazdur, Richard

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2013  Volume 19, Issue 17, Page(s) 4559–4563

    Abstract: The U.S. Food and Drug Administration (FDA) review leading to accelerated approval of carfilzomib is described. A single-arm trial enrolled 266 patients with multiple myeloma refractory to the most recent therapy who had received prior treatment with ... ...

    Abstract The U.S. Food and Drug Administration (FDA) review leading to accelerated approval of carfilzomib is described. A single-arm trial enrolled 266 patients with multiple myeloma refractory to the most recent therapy who had received prior treatment with bortezomib and an immunomodulatory agent (IMID). Patients received carfilzomib by intravenous infusion over 2 to 10 minutes at a dose of 20 mg/m2 on days 1, 2, 8, 9, 15, and 16 of the 28 days of cycle 1, and at a dose of 27 mg/m2 on the same schedule in cycle 2 and subsequent cycles. The primary efficacy endpoint was overall response rate (ORR) as determined by an independent review committee using International Myeloma Working Group Uniform Response Criteria. The safety of carfilzomib was evaluated in 526 patients with multiple myeloma treated with various dosing regimens. The ORR was 23%. The median duration of response was 7.8 months. The most common adverse reactions associated with carfilzomib infusion were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and fever. The most common serious adverse events were pneumonia, acute renal failure, fever, and congestive heart failure. Infusion reactions to carfilzomib could be reduced by pretreatment with dexamethasone and intravenous fluids. On July 20, 2012, the FDA granted accelerated approval of carfilzomib for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an IMID and who have shown disease progression while on therapy or within 60 days of completion of the last therapy.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Clinical Trials as Topic ; Drug Approval ; Drug-Related Side Effects and Adverse Reactions/pathology ; Female ; Humans ; Male ; Middle Aged ; Multiple Myeloma/drug therapy ; Multiple Myeloma/pathology ; Oligopeptides/adverse effects ; Oligopeptides/therapeutic use ; Proteasome Inhibitors/adverse effects ; Proteasome Inhibitors/therapeutic use ; United States ; United States Food and Drug Administration
    Chemical Substances Oligopeptides ; Proteasome Inhibitors ; carfilzomib (72X6E3J5AR)
    Language English
    Publishing date 2013-09-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-13-0755
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: U.S. Food and Drug Administration approval: panitumumab for epidermal growth factor receptor-expressing metastatic colorectal carcinoma with progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

    Giusti, Ruthann M / Shastri, Kaushikkumar / Pilaro, Anne M / Fuchs, Chana / Cordoba-Rodriguez, Ruth / Koti, Kallappa / Rothmann, Mark / Men, Angela Yuxin / Zhao, Hong / Hughes, Monica / Keegan, Patricia / Weiss, Karen D / Pazdur, Richard

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2008  Volume 14, Issue 5, Page(s) 1296–1302

    Abstract: Purpose: To describe the Food and Drug Administration review and marketing approval considerations for panitumumab (Vectibix) for the third-line treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal carcinoma.: ... ...

    Abstract Purpose: To describe the Food and Drug Administration review and marketing approval considerations for panitumumab (Vectibix) for the third-line treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal carcinoma.
    Experimental design: Food and Drug Administration reviewed a single, open-label, multicenter trial in which 463 patients with epidermal growth factor receptor-expressing metastatic colorectal cancer who had progressed on or following treatment with a regimen containing a fluoropyrimidine, oxaliplatin, and irinotecan were randomized (1:1) to receive best supportive care (BSC) with or without panitumumab (6 mg/kg every other week) administered until disease progression or intolerable toxicity. Progression and response were confirmed by an independent review committee masked to treatment assignment. At progression, patients in the BSC-alone arm were eligible to receive panitumumab.
    Results: Although median progression-free survival (PFS) was similar in both treatment arms ( approximately 8 weeks), the mean PFS was approximately 50% longer among patients receiving panitumumab than among those receiving BSC alone (96 versus 60 days, respectively) and the objective response rate in patients receiving panitumumab was 8%. However, no difference in overall survival was shown between the two study arms.
    Conclusions: Panitumumab received accelerated approval based on improvement in PFS and an independently confirmed response rate of 8%, similar to that observed with other active agents at this advanced stage of disease. Confirmation of clinical benefit will be required for full approval.
    MeSH term(s) Adult ; Aged ; Antibodies, Monoclonal/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Camptothecin/administration & dosage ; Camptothecin/analogs & derivatives ; Chemotherapy, Adjuvant ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/metabolism ; Colorectal Neoplasms/pathology ; Disease Progression ; Disease-Free Survival ; Drug Approval ; Fluorouracil/administration & dosage ; Humans ; Liver Neoplasms/drug therapy ; Liver Neoplasms/metabolism ; Liver Neoplasms/secondary ; Lung Neoplasms/drug therapy ; Lung Neoplasms/metabolism ; Lung Neoplasms/secondary ; Lymphatic Metastasis ; Male ; Middle Aged ; Organoplatinum Compounds/administration & dosage ; Receptor, Epidermal Growth Factor/metabolism ; Survival Rate ; United States ; United States Food and Drug Administration
    Chemical Substances Antibodies, Monoclonal ; Organoplatinum Compounds ; oxaliplatin (04ZR38536J) ; panitumumab (6A901E312A) ; irinotecan (7673326042) ; Receptor, Epidermal Growth Factor (EC 2.7.10.1) ; Fluorouracil (U3P01618RT) ; Camptothecin (XT3Z54Z28A)
    Language English
    Publishing date 2008-03-01
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-07-1354
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: U.S. Food and Drug Administration approval summary: brentuximab vedotin for the treatment of relapsed Hodgkin lymphoma or relapsed systemic anaplastic large-cell lymphoma.

    de Claro, R Angelo / McGinn, Karen / Kwitkowski, Virginia / Bullock, Julie / Khandelwal, Aakanksha / Habtemariam, Bahru / Ouyang, Yanli / Saber, Haleh / Lee, Kyung / Koti, Kallappa / Rothmann, Mark / Shapiro, Marjorie / Borrego, Francisco / Clouse, Kathleen / Chen, Xiao Hong / Brown, Janice / Akinsanya, Lara / Kane, Robert / Kaminskas, Edvardas /
    Farrell, Ann / Pazdur, Richard

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2012  Volume 18, Issue 21, Page(s) 5845–5849

    Abstract: The U.S. Food and Drug Administration (FDA) describes the accelerated approval of brentuximab vedotin for patients with relapsed Hodgkin lymphoma and relapsed systemic anaplastic large-cell lymphoma (sALCL). FDA analyzed the results of two single-arm ... ...

    Abstract The U.S. Food and Drug Administration (FDA) describes the accelerated approval of brentuximab vedotin for patients with relapsed Hodgkin lymphoma and relapsed systemic anaplastic large-cell lymphoma (sALCL). FDA analyzed the results of two single-arm trials, enrolling 102 patients with Hodgkin lymphoma and 58 patients with sALCL. Both trials had primary endpoints of objective response rate (ORR) and key secondary endpoints of response duration and complete response (CR) rate. For patients with Hodgkin lymphoma, ORR was 73% (95% CI, 65-83%); median response duration was 6.7 months, and CR was 32% (95% CI, 23-42%). For patients with sALCL, ORR was 86% (95% CI, 77-95%), median response duration was 12.6 months, and CR was 57% (95% CI, 44-70%). The most common adverse reactions were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory infection, diarrhea, pyrexia, rash, thrombocytopenia, cough, and vomiting. FDA granted accelerated approval of brentuximab vedotin for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplantation (ASCT) or after failure of at least two prior multiagent chemotherapy regimens in patients who are not ASCT candidates, and for the treatment of patients with sALCL after failure of at least one prior multiagent chemotherapy regimen.
    MeSH term(s) Adult ; Aged ; Antineoplastic Agents/therapeutic use ; Drug Approval ; Hodgkin Disease/drug therapy ; Humans ; Immunoconjugates/therapeutic use ; Ki-1 Antigen/immunology ; Ki-1 Antigen/metabolism ; Lymphoma, Large-Cell, Anaplastic/drug therapy ; Middle Aged ; Recurrence ; Treatment Outcome ; United States ; United States Food and Drug Administration ; Young Adult
    Chemical Substances Antineoplastic Agents ; Immunoconjugates ; Ki-1 Antigen ; brentuximab vedotin (7XL5ISS668)
    Language English
    Publishing date 2012-11-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-12-1803
    Database MEDical Literature Analysis and Retrieval System OnLINE

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