GIOVANNI MENDONCA BARIANI

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Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina - Médico

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  • article 13 Citação(ões) na Scopus
    Poor Evidence to Standardize Adjuvant Treatment for Patients With Biliary Tract Cancer
    (2012) BARIANI, Giovanni M.; BRAGHIROLI, Maria Ignez; RIECHELMANN, Rachel P.
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    THE QUALITY OF SAMPLE SIZE CALCULATION (SSC) REPORTING IN CANCER CLINICAL TRIALS
    (2012) BARIANI, G. M.; FERRARI, A. C. R. C.; HOFF, P. M.; ARAI, R.; PRECIVALE, M.; RIECHELMANN, R. P.
    Background SSC is a pivotal step in clinical trial concept and design. It determines the chance of detecting a significant result, ensures appropriate power, and helps sponsors to allocate adequate resources into trials. Here we describe the frequency with which randomized cancer clinical trials (RCT) report the data required for SSC. Methods We systematically searched for phase III RCT published in top clinical oncology journals which were accompanied by editorials from Jan 2008 to Oct 2011. We assumed that RCT discussed by editorialists were clinically important. Two blinded investigators extracted data on SSC. Table 1 describes the information required for SSC according to variable type used for primary endpoint. Results 140 out of 150 RCT were eligible. Median sample size was 596 subjects (50-40,000) per RCT. In 65.7% of RCT, the number of enrolled subjects was at least 90% of the planned sample size. The primary endpoint was a categorical variable in 10.0%, continuous in 27.9%, and time-to-event in 62.1%. In general, 80.7% reported a planned sample size, 57.9% described their null hypothesis (H0), with 20.7% giving a scientific rationale for H0. 57.9% informed their alternative hypothesis (H1). Alpha (α) and beta (β) errors were explicit in 92.9% and 90.7%, respectively. Expected difference between arms was reported in 88.6%. Only 2.9% of RCT provided all information for proper SSC (required and optional, Table). Excluding “optional information”, SSC could be reproducible in 18.6% of RCT. Conclusion Regardless of the CONSORT 2010 statement, the quality of SSC reporting in phase III cancer RCT seems inadequate. This may compromise future study designs, pooling of data and interpretation of results. Lack of transparency in SSC reporting may also have ethical implications. Variable Type Required information Optional information Categorical H1H0 Expected difference between arms (delta) α and β errors Dropout rate Statistical test used for SSC Scientific rationale for H0 and H1 Continuous H1H0 Delta Standard deviation for both arms α and β errors Same as above Time-to-event H1H0 Delta (hazard ratio) Length of recruitment Length of follow up for each patient α and β errors Same as above Information necessary for SSC
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    METRONOMIC ORAL CYCLOPHOSPHAMIDE IN THE TREATMENT OF METASTATIC SOFT TISSUE SARCOMA: IS THERE A ROLE FOR MAINTENANCE THERAPY?
    (2012) FERRARI, A. C. R.; CAMARGO, V. P.; BARIANI, G. M.; GONCALVES, M. S.; HOFF, P. M.; CASTRO JR., G. De
    Background Metronomic chemotherapy has been demonstrated to improve DFS in advanced STS. Here we aimed to analyze the efficacy and safety of metronomic oral cyclophosphamide (M-CTX) as maintenance or salvage therapy in these patients (pts). Methods It is a retrospective study of all advanced/metastatic STS pts (RMS, GIST, bone sarcomas excluded) treated in our institution between Feb/2009 and Jan/2012 with M-CTX 100 mg PO daily 21 out of 28 days, until disease progression (DP). Tumor response (RECIST 1.1) was assessed every 2 cycles. The primary endpoint of the study was time to treatment failure (TTF). Toxicity was graded according to the NCI-CTC v.3.0. criteria. Results 27 pts were consecutively included in this analysis. Thirteen pts received M-CTX as maintenance chemotherapy after presenting best response: median age 60 y, 9 female; 5 LMS, 3 HGUPS, 2 PNET, 3 others. Median number of previous chemotherapy regimens 2; 9 previously treated with doxorubicin and 4 with ifosfamide; 4 presented PR as best response. Median TTF (mTTF) was 9.2 mo, 4 pts (2 PNET, 1 LMS, 1 HGUPS) had mTTFs ≥ 6 mo and no deaths were observed in a median follow-up of 7 mo. 14 pts received M-CTX as salvage chemotherapy after DP: median age 45.5 y, 8 female; 3 LMS, 3 HGUPS, 3 synovial, 2 ASPS, 3 others. Median number of previous chemotherapy regimens 1.5; 11 previously treated with doxorubicin and 6 with ifosfamide; 1 PR as best response. mTTF 3.3 mo, 1 ASPS had mTTFs ≥ 6 mo, and 9 deaths (HR 1.403, 95%CI 0.608-3.236, p = 0.409, in comparison with maintenance strategy). In general, M-CTX was well tolerated, and the most common toxicity (>10%) included nausea G1 (5 pts), renal failure (3 pts), anemia G1 (4 pts), anemia G2 (3 pts), lymphopenia G1 (12 pts). Conclusions Metronomic oral cyclophosphamide seems to be a valid option as maintenance chemotherapy after presenting best response in advanced/metastatic STS, with acceptable toxicity. This compares favorably with historical controls (mPFS around 4 months). However, after disease progression, it is a futile chemotherapy regimen. Disclosure A.C.R. Ferrari: Travel expenses covered: Roche.
  • conferenceObject
    Self-reported conflicts of interest (sfCOI) of authors and the interpretation of randomized phase III trials (RCT) and related editorials (REd) in cancer research
    (2012) BARIANI, Giovanni Mendonca; FERRARI, Anezka Carvalho Rubin De Celis; HOFF, Paulo Marcelo; RIECHELMANN, Rachel
    Background: Growing participation from industry in cancer research has resulted in increased reporting of COI. We aimed to test any association between author’s conclusion and sfCOI in cancer studies. Methods: All RCT and REd published in 6 major cancer journals in a 3.5 year period were selected. Two investigators blinded to COI disclosure independently analyzed each RCT and REd, classifying authors’ conclusions as highly positive, positive, neutral, negative, and highly negative with respect to author’s opinion on the experimental therapy. The agreement rate between investigators for conclusion classification was 90% (consensus was achieved for the remaining 10%). We also collected data on study results, COI and sponsorship. COI was defined as any self-reported financial tie between author and industry except for research funds. Predictors of positive/highly positive conclusions of RCT and of REd were tested separately in logistic regression multivariable models. Results: From Jan 2008 to Oct 2011, 1,485 articles were retrieved: 150 RCT and 140 REd were eligible. Among the RCT, 82 (55%) were positive, and 78 (52%) were entirely or partially funded by industry. Any sfCOI was present in 103 (69%) RCT and in 71 (47%) REd. Conclusions of REd and RCT were: 7.3% and 11.3% highly positive, 42.7% and 57.3% positive, 8.0% and 2.0% neutral, 29.3% and 18.7% negative, and 12.7% and 10.7% highly negative, respectively. Multivariable analysis showed that RCT positive result was the only significant predictor for positive conclusion by RCT authors (OR=109, 95% CI: 21-567; p<0.001). The only factor associated with positive conclusions of REd authors was a positive conclusion by RCT author (OR=42, 95% CI: 7-244; p<0.001). While 64 (43%) RCT reported negative results, 103 (68.7%) RCT authors interpreted studies positively. Logistic regression for discordance between RCT result and RCT conclusion did not find any association with COI. Conclusions: The interpretation of RCT results by authors was not influenced by sfCOI or trial sponsorship. Authors of REd were not influenced by study results or by their sfCOI when discussing cancer RCT.