Gemcitabine Doublets in Advanced Pancreatic Cancer: Should We Move On?

Lima, Caio Max Sao Pedro Rocha; Flores, Aurea M.

doi:10.1200/jco.2005.03.8315

Cited by 10 publications

(3 citation statements)

References 31 publications

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“…In view of the potential limitations of literature‐based meta‐analyses and of the conflicting results reported by other authors using similar approaches,29, 30, 32 we believe that a meta‐analysis based on individual patient data would be of great value. Although progress in the systemic treatment of patients with advanced PDAC in the past 10 years appears to be small, rather than fostering therapeutic nihilism, the current data should prompt a profound revision of our approach to clinical research in pancreatic cancer37 that takes into account the need for identification of novel targets, more accurate preclinical/early clinical target validation, more extensive and innovative Phase II testing, and identification and validation of alternative surrogate markers for clinical efficacy.…”

Section: Discussionmentioning

confidence: 99%

Gemcitabine‐based combinations for inoperable pancreatic cancer: Have we made real progress?

Bria

Milella

Gelibter³

et al. 2007

Cancer

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BACKGROUND.Several attempts have been made at improving the efficacy of gemcitabine in advanced pancreatic cancer by combining it with other chemotherapeutic or molecularly targeted agents. However, randomized trials have produced conflicting results.METHODS.All prospective, randomized, phase 3 trials that compared single‐agent gemcitabine with gemcitabine‐based combinations were considered eligible for the current analysis. A literature‐based meta‐analysis was performed, event‐based relative risk ratios with 95% confidence intervals were derived through both a fixed‐effect model approach and a random‐effect model approach, and overall survival (OS) was explored as the primary endpoint. To estimate the magnitude of the eventual benefit, absolute differences and the number of patients needed to treat (NNT) for 1 patient to benefit were calculated. A sensitivity analysis for OS was performed according to the type of agent used in combination with gemcitabine.RESULTS.Twenty trials that involved 6296 patients were identified. No significant differences in the primary endpoint were observed in the overall population or in the sensitivity analysis. Conversely, a significant advantage was evident with regard to both progression‐free survival (PFS) and the overall response rate (ORR) in the overall population, with an absolute benefit of 2.6% (NTT = 39 patients) and 3.0% (NNT = 33 patients). Platinum combinations led to the greatest absolute benefits for PFS and ORR compared with single‐agent gemcitabine (10% and 6.5%, respectively), but this did not result in an OS benefit. Improvement in PFS, but not in the ORR, was correlated with an improvement in OS.CONCLUSIONS.Single‐agent gemcitabine remains the standard of care for patients with advanced pancreatic cancer. However, platinum/gemcitabine combinations appeared to improve PFS and the ORR and, thus, may be considered in selected patients. Cancer 2007. © 2007 American Cancer Society.

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Section: Discussionmentioning

confidence: 99%

Gemcitabine‐based combinations for inoperable pancreatic cancer: Have we made real progress?

Bria

Milella

Gelibter³

et al. 2007

Cancer

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“…Inasmuch as Stage IV pancreatic cancer represents one of the most difficult and deadly forms of cancer, wherein the most advanced of the biologic 'blockbusters' (32,33) and the most extensive arrays of combinatorial chemotherapies (31,39) have failed to reach anything but a nadir in modern medical praxis (28), these noteworthy cases, where Rexin-G at sufficient doses has served to turn the tide of the intractable disease, teaches physicians of the future that it is no longer impossible to manage this dreadful disease. It teaches: i) the advantages of administering Rexin-G as soon as possible in the treatment regimens, ii) the necessity to hold-the-course in the absence of overt toxicity, iii) the empowerment of surgical oncologists with an effective neoadjuvant/adjuvant, who are now able do more for their patients who were previously considered inoperable; it teaches iv) the predictable mechanisms-of-action and v) the revitalization of medicinal pharmacology with the advancement of a singular moleculargenetic medicine and the assertion of a simple treatment formula: [Rexin-G plus X is greater than X] in terms of clinical efficacy and thus improved patient outcome.…”

Section: Discussionmentioning

confidence: 99%

Noteworthy clinical case studies in cancer gene therapy: Tumor-targeted Rexin-G advances as an efficacious anti-cancer agent

Гордон¹

2010

Int J Oncol

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Abstract. The advent of pathotropic (disease-seeking) targeting technology has ushered cancer gene therapy across the threshold of history, marking the beginning of a new epoch of medical praxis. For the first time, clinical oncologists can reach beyond the finest of catheters, beyond the reach of the most gifted surgeons, to the very fabric of metastatic disease in an effort to halt the progression and turn the tide of otherwise intractable cancers. The enabling molecular biotechnologies embodied in the leading tumor-targeted agent, Rexin-G, and its timely development as a safe and effective anti-cancer drug -from oncogene discovery and target validation, to molecular engineering of the core nanotechnologies, to the first clinical proofs-of principle, confirmatory trials, expanded access programs, and accelerated regulatory approvals -have been extensively documented in the medical literature. Therefore, this paper represents a final chapter, highlighting a series of noteworthy cases studies in the emergent field of targeted genetic medicine: case studies which, in and of themselves, reveal vital and important aspects of the molecular-genetic bio-pharmacology, advanced clinical protocols, refinement of patient monitoring, expanding treatment options, and strategic medical approaches to patient care that exemplify and thereby extend the established principles of pathotropic targeting and cancer gene therapy to a new generation of clinical practitioners.

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“…Approximately 60%-70% of patients with advanced PC are at the metastatic stage, with mOS of only 3-5 months. [2][3][4][5][6][7][8][9] Unfortunately, the current regimens are unsatisfactory. Encouraging the achievement of new regimens has been developed in many other cancer fields but rarely in PC.…”

Section: Introductionmentioning

confidence: 99%

Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer

Qin,

Li,

Bai

et al. 2023

JCO

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Gemcitabine Doublets in Advanced Pancreatic Cancer: Should We Move On?

Cited by 10 publications

References 31 publications

Gemcitabine‐based combinations for inoperable pancreatic cancer: Have we made real progress?

Gemcitabine‐based combinations for inoperable pancreatic cancer: Have we made real progress?

Noteworthy clinical case studies in cancer gene therapy: Tumor-targeted Rexin-G advances as an efficacious anti-cancer agent

Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer

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