Treatment of inoperable non-small-cell bronchogenic carcinoma with etoposide and cis-platinum

Mitrou, P. S.; Fischer, Markus; Weißenfels, I.; Diehl, Volker; Gropp, C.; Liesenfeld, A.; Schmidt, Marlene; Berdel, Wolfgang E.; Fink, U.; Graubner, M.

doi:10.1016/s0305-7372(82)80093-5

Cited by 7 publications

(2 citation statements)

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“…Longeval and Klastersky used cisplatin and etoposide in 94 patients with advanced NSCLC: A 38% response rate and a median survival of 7.5 months were noted 23. The accumulated response rate of cisplatin and etoposide in 647 patients from 7 trials was 28% (20–30%) 24–30. The median survival times in these 7 studies ranged from 24.5 weeks to 32 weeks.…”

Section: Discussionmentioning

confidence: 99%

High dose tamoxifen plus cisplatin and etoposide in the treatment of patients with advanced, inoperable nonsmall cell lung carcinoma

Yang

Cheng

Yeh

et al. 1999

Cancer

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BACKGROUND Tamoxifen sensitizes cancer cells to chemotherapeutic agents. High dose tamoxifen has been tested in the treatment of patients with melanoma and other cancers. The authors conducted a Phase II study of high dose tamoxifen plus cisplatin and etoposide for patients with advanced, inoperable nonsmall cell lung carcinoma. METHODS Patients with Stage IIIB, Stage IV, or recurrent disease; good performance status; measurable lesions; and good organ function were eligible. Tamoxifen 150 mg/m2/day, divided into 4 doses, was given for 8 days. Cisplatin 60 mg/m2 was given on Day 4. Etoposide 60 mg/m2/day was given on Days 4–8. Patients were allowed to remain in the study until either intolerable toxicity was observed or disease progression occurred. RESULTS Forty patients were accrued and received a total of 191 cycles of treatment. All patients were evaluable for response and toxicity. One patient had a complete remission and 14 had a partial remission (overall response rate, 37.5%). The median survival was 47 weeks. One‐year survival was 44%. Increased thrombotic episodes were noted; all were clinically manageable. CONCLUSIONS High dose tamoxifen can be administered safely in combination with cisplatin and etoposide to patients with advanced nonsmall cell lung carcinoma. Favorable response rates and survival times were obtained. The value of high dose tamoxifen in the treatment of patients with nonsmall cell lung carcinoma can be evaluated further in randomized Phase III studies. Cancer 1999;86:415–20. © 1999 American Cancer Society.

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Section: Discussionmentioning

confidence: 99%

High dose tamoxifen plus cisplatin and etoposide in the treatment of patients with advanced, inoperable nonsmall cell lung carcinoma

Yang

Cheng

Yeh

et al. 1999

Cancer

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“…The calculated costs for such a trial were negligible as treatment was reimbursed by health insurances as a standard of care and patient surveillance plus documentation were performed by the investigators as standard tasks within clinical patient care. Again, publication of this trial with results on 26 patients appeared within 1 year in an international peer-reviewed journal [ 4 ]. The treatment of advanced NSCLC with cisplatin doublets soon became standard of care.…”

Section: Trial Activation and Conduct Before 2004mentioning

confidence: 99%

Activation of Investigator-Initiated Clinical Trials with a Pharmaceutical for Cancer Patients before and after Post-Millennial Changes of Regulations in Germany and Europe

Berdel

2022

Cancers

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Shortly after the beginning of the year 2000, multiple legal changes with impacts on the regulatory framework of clinical trials became effective almost simultaneously. They included the European Union (EU) Clinical Trial Directive (CTD) 2001/20 followed by major changes in national drug laws, the change in the legal status of German University Hospitals (1998), and a new disease-related groups (DRG)-based reimbursement system for hospitals in Germany (2000). Together, these changes created enormous bureaucratic and financial inhibition of activation and conduct of academic investigator-initiated clinical trials (IIT). Examples for activating clinical trials in oncology before and after 2004 are outlined and discussed, focussing on extended time frames, the establishment of centralized responsibility structures and the exploding financial consequences. In addition, the evolution of trial numbers and the distribution of trial initiators between “commercial” and “academic” over time are discussed together with the occurrence of clinical registries. At the same time, progress in molecular biology led to a plethora of new targets for effective pharmacological therapy of life-threatening diseases such as cancer, and the overall number of clinical trials has not decreased. Yet, judging the regulatory and administrative hurdles between scientific study design and first-patient on trial before and after 2004 and weighing these against the lack of evidence that this regulation has achieved its goal to enhance patient safety and trial quality, the necessity to completely overhaul this CTD becomes obvious. A main goal of such an initiative should be to minimize bureaucracy. For the specific situation in Germany, relocation of responsibility and freedom to operate in University Hospitals and Medical Faculties back to the physician–scientists and reduction in interference by legal divisions should be a goal as well as increasing the public financial support for IITs.

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Die Stellung von Etoposid in der Behandlung des Bronchuskarzinoms Erfahrungen der Schweizerischen Arbeitsgruppe für klinische Krebsforschung (SAKK)

Hofmann¹,

Joss²,

Jungi

et al. 1984

Etoposid (VP 16-213) in Der Therapie Maligner Erkrankungen

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Treatment of inoperable non-small-cell bronchogenic carcinoma with etoposide and cis-platinum

Cited by 7 publications

References 0 publications

High dose tamoxifen plus cisplatin and etoposide in the treatment of patients with advanced, inoperable nonsmall cell lung carcinoma

High dose tamoxifen plus cisplatin and etoposide in the treatment of patients with advanced, inoperable nonsmall cell lung carcinoma

Activation of Investigator-Initiated Clinical Trials with a Pharmaceutical for Cancer Patients before and after Post-Millennial Changes of Regulations in Germany and Europe

Die Stellung von Etoposid in der Behandlung des Bronchuskarzinoms Erfahrungen der Schweizerischen Arbeitsgruppe für klinische Krebsforschung (SAKK)

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