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2. Guidelines for analysis and reporting of clinical trials in oncology.

Author

Piantadosi, S, Saijo, N, and Tamura, T

Subjects
Humans, Data Collection, Medical Oncology, Writing, Clinical Trials as Topic, Practice Guidelines as Topic, Oncology & Carcinogenesis
Abstract

When analyzing and reporting the results of clinical trials, investigators should follow a simple approach. The purpose of a trial is to estimate an effect or treatment difference, which if present would have clinical utility when treating new patients. Procedures or methods that do not facilitate precisely and impartially estimating and reporting the treatment effect are likely to mislead investigators. Most often in clinical trials, investigators are interested in estimates of risk ratios (specifically odds or hazard ratios) between the treatment groups or levels of a prognostic factor. These simple ideas suggest that the most useful results from clinical trials will be estimated risk ratios and their confidence limits. Especially in cancer, where disease progression, recurrence, and death are common events following treatment, estimates of risk difference are very relevant. Hypothesis tests and associated P-values, although often (or exclusively) reported, are of lesser utility because they do not fully summarize the data. These recommendations may be seen by some investigators to be contrary to accepted practice. It is true that they are somewhat contrary to common practice but their general acceptance is evident in many journals and presentations by clinical trial methodologists. Despite some disagreement among statisticians regarding the need for adjustment of analyses for imbalanced prognostic factors, it is helpful to see if treatment effects change after accounting for imbalances. When this occurs, it may be of clinical interest. Although we discourage analyses that exclude any patients who meet the eligibility criteria, some circumstances will require that this be done (e.g., when a patient refuses to participate after randomization). Investigators should report, and emphasize as primary, those analyses that include all eligible patients. It is our hope and belief that analysis and reporting of trial results along the guidelines suggested here will result in impartial and useful information for journal readers.

Published
1993

19. Genetic Variations and Haplotype Structures of the ABCB1 Gene in a Japanese Population: An Expanded Haplotype Block Covering the Distal Promoter Region, and Associated Ethnic Differences

Author

Sai, K., Itoda, M., Saito, Y., Kurose, K., Katori, N., Kaniwa, N., Komamura, K., Kotake, T., Morishita, H., Tomoike, H., Kamakura, S., Kitakaze, M., Tamura, T., Yamamoto, N., Kunitoh, H., Yamada, Y., Ohe, Y., Shimada, Y., Shirao, K., Minami, H., Ohtsu, A., Yoshida, T., Saijo, N., Kamatani, N., Ozawa, S., and Sawada, J.

Published
2006

35. Nivolumab treatment beyond progressive disease in advanced non-small cell lung cancer.

Author

Enomoto, T., Tamiya, A., Matsumoto, K., Adachi, Y., Azuma, K., Inagaki, Y., Kouno, S., Taniguchi, Y., Saijo, N., Okishio, K., and Atagi, S.

Abstract

Purpose: This study evaluated the efficacy and safety of nivolumab treatment beyond progressive disease (PD) in non-small cell lung cancer (NSCLC). Patients/methods: Medical records of consecutive patients with advanced NSCLC who received nivolumab between December 2015 and December 2018 were reviewed. Clinical outcomes of three groups of eligible patients who received nivolumab as a second-line treatment after PD were compared based on Response Evaluation Criteria in Solid Tumors v1.1. We conducted subgroup analyses in patients with and without new lesions at first PD. Results: Twenty-eight patients continued nivolumab treatment beyond PD (TBP). Post PD, 46 patients switched to other anti-cancer treatment (OAT), and 21 received no further anti-cancer treatment (NAT). There were no significant differences in overall survival (OS) or survival post progression (SPP) between TBP and OAT groups (OS: 15.6 vs. 13.4 months, P =.40, SPP: 12.2 vs. 9.3 months, P =.42). Subgroup analyses indicated that among patients without new lesions at first PD, SPP was longer in the TBP than in the OAT groups (12.6 vs. 9.3 months, P =.22, HR: 0.64; 95% CI 0.31‒1.31). The frequency of immune-related adverse events leading to discontinuation during nivolumab beyond PD was equivalent to that for pre-PD (10.7 vs. 12.6%). Conclusions: No significant benefits were associated with continuation of nivolumab for advanced NSCLC patients. Continuation of nivolumab beyond PD could be a more useful option in patients without new lesions at first PD. Treatment-related toxicities require attention during nivolumab treatment not only before PD but also beyond PD. [ABSTRACT FROM AUTHOR]

Published
2021
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42. The efficacy of dose reduced crizotinib for advanced ALK-positive non-small cell lung cancer

Author

Naito, M., primary, Naoki, Y., additional, Takata, S., additional, Ishii, S., additional, Taniguchi, Y., additional, Saijo, N., additional, Tamiya, A., additional, Omachi, N., additional, Okishio, K., additional, Morita, S., additional, Tanaka, A., additional, Shiroyama, T., additional, Morishita, N., additional, Suzuki, H., additional, Okamoto, N., additional, Hirashima, T., additional, and Atagi, S., additional

Published
2017
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43. Nab-paclitaxel in combination with carboplatin versus docetaxel in chemotherapy-naïve with advanced non-small-cell lung cancer aged 75 years old or more: Retrospective cohort study

Author

Katayama, K., primary, Tamiya, A., additional, Tanaka, Y., additional, Nakahama, K., additional, Taniguchi, Y., additional, Saijo, N., additional, Naoki, Y., additional, Omachi, N., additional, Okishio, K., additional, Kasai, T., additional, and Atagi, S., additional

Published
2017
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45. Final analysis of phase II trial of carboplatin, S-1, and gefitinib as first-line triplet chemotherapy for advanced non-small cell lung cancer patients with activating epidermal growth factor receptor mutations

Author

Tanaka, A., primary, Tamiya, A., additional, Tamiya, M., additional, Morita, S., additional, Shiroyama, T., additional, Saijo, N., additional, Minomo, S., additional, Tsuji, T., additional, Takeuchi, N., additional, Omachi, N., additional, Morishita, N., additional, Suzuki, H., additional, Okamoto, N., additional, Okishio, K., additional, Hirashima, T., additional, and Atagi, S., additional

Published
2017
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49. Dose-finding study of irinotecan and cisplatin plus concurrent radiotherapy for unresectable stage III non-small-cell lung cancer [seecomments]

Author

Yokoyama, A., Kurita, Y., Saijo, N., Tamura, T., Noda, K., Shimokata, K., and Matsuda, T.

Subjects
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Humans, neoplasms, Research Article
Abstract

Irinotecan hydrochloride (CPT-11) shows marked anti-tumour activity alone and in combination with cisplatin in non-small-cell lung cancer (NSCLC). It is necessary to investigate combined-modality therapy including novel effective anti-cancer agents to improve long-term survival of patients with unresectable stage III NSCLC. A phase I/II study of concurrent chemoradiotherapy with CPT-11 and cisplatin was conducted to determine the maximum tolerated dose (MTD) and efficacy in this group of patients. Thirteen previously untreated patients with unresectable stage IIIA/B NSCLC were enrolled and efficacy and toxicity was evaluated in 12 of them; one patient was ineligible. Chemotherapy was repeated every 4 weeks for three courses. Radiation therapy was started on day 2 of the first course of chemotherapy and 60 Gy in 30 fractions was given over 6 weeks. Four of six patients enrolled at level 1 completed the scheduled treatment. Another two received only one and two courses of chemotherapy as a result of persistent leucopenia and neutropenic fever respectively. Three of six patients given level 2 therapy completed the scheduled treatment. Another three received only one and two courses of chemotherapy, two refused treatment because of diarrhoea and one died of pneumonia. Radiation therapy was inadequate in these three patients. As the CPT-11 dose intensity in this trial was low, because of the necessity of omitting CPT-11 administration on days 8 and/or 15 as a result of leucopenia or diarrhoea, and the low radiation therapy completion rate, the trial was discontinued at level 2. Five patients at level 1 and three at level 2 showed partial responses, an overall response rate of 67%. Although neither MTD nor dose-limiting toxicity could be identified, chemotherapy with CPT-11 and cisplatin plus concurrent radiation therapy was deemed unacceptable. We are now conducting a phase I/II study of chemotherapy using CPT-11 as a single agent in combination with radiation therapy.

Published
1998

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