Docetaxel-cisplatin (DC) versus 5-fluorouracil-leucovorin-cisplatin (FLC) as first-line treatment for locally advanced or metastatic gastric cancer: Preliminary results of a phase III study

Ridwelski, K.; Fahlke, J.; Kettner, E.; Schmidt, Carl J.; Keilholz, Ulrich; Quietzsch, D.; Aßmann, Michael; Stauch, Martina; Zierau, K.; Lippert, H.

doi:10.1200/jco.2008.26.15_suppl.4512

Cited by 13 publications

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“…A second phase III trial in inoperable gastric cancer patients compared docetaxel/cisplatin versus 5FU/cisplatin [3]. Both combinations showed comparable response rates and comparable overall survival of 9.4 and 10.2 months, respectively.…”

Section: Palliative Chemotherapymentioning

confidence: 95%

“…Given the substantial diff erences of S1 pharmacokinetics and because of the high interethnic variability [2] it remains to be shown whether this substance proves its effi cacy in a Caucasian population. Th e large international FLAGS trial investigating this issue in a western population will help to answer this question.A second phase III trial in inoperable gastric cancer patients compared docetaxel/cisplatin versus 5FU/cisplatin [3]. Both combinations showed comparable response rates and comparable overall survival of 9.4 and 10.2 months, respectively.…”

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confidence: 95%

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Gastric cancer

Wöll¹

2008

memo

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Overall survival of patients suff ering from gastric cancer is still poor. Two-thirds of patients are diagnosed in a locally advanced stage or with metastatic tumour. But even in patients with operable disease recurrence rate is high. To increase the prognosis of this devastating disease much eff ort has been put in the development of curative and palliative therapy concepts recently. Th e aim of this article is to summarize the most important publications at this year's ASCO meeting and to put them into context of current therapeutic strategies. Palliative chemotherapyAn Asian phase III trial investigated the eff ect of the oral 5FU prodrug S1 in combination with 5FU compared to S1 and cisplatin or S1 monotherapy [1]. Th e combination S1 and cisplatin was superior to 5FU/S1 or S1 monotherapy as far as response rate and overall survival are concerned. Th e authors conclude that this will be the new Chinese standard. Given the substantial diff erences of S1 pharmacokinetics and because of the high interethnic variability [2] it remains to be shown whether this substance proves its effi cacy in a Caucasian population. Th e large international FLAGS trial investigating this issue in a western population will help to answer this question.A second phase III trial in inoperable gastric cancer patients compared docetaxel/cisplatin versus 5FU/cisplatin [3]. Both combinations showed comparable response rates and comparable overall survival of 9.4 and 10.2 months, respectively. Th e only diff erence could be shown in toxicity. Docetaxel/cisplatin showed more haematotoxicity whereas 5FU/cisplatin showed more gastrointestinal side eff ects.An interim analysis of a large (n = 3106, 17 randomized trials) individual patient data-based meta-analysis elucidated the benefi t of FU derivatives, anthracyclines, platinum salts, taxanes or irinotecan in the palliative setting [4]. Only the taxane-based regimens showed an overall survival benefi t compared with all other combinations but this result is mainly based on two trials. Th erefore fi nal analysis of this meta-analysis has to be awaited until conclusions can be drawn.Many phase II trials investigated diff erent chemotherapy doublets or triplets (Tab. 1). Th ese data support the role of taxanes, capecitabin, oxaliplatin as well as 5FU and cisplatin as active substances in the treatment of gastric cancer. Two phase II trials investigated sequential therapy strategies showing comparable effi cacy but lower toxicity (Tab. 2) making this approach interesting for the generation of future trials.Even in second and third line therapies phase II trials showed effi cacy (Tab. 3). In this partially heavily pre-treated cohort remission rates between 18% and 34% could be achieved with overall survival from 5 to 15 months. Although phase III trials in this setting are most likely unrealistic these phase II data among earlier trials favour second or even third line chemotherapy in selected patients. BiologicalsOnly phase II data are available as far as targeted therapies are concerned. Cetux...

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Section: Palliative Chemotherapymentioning

confidence: 95%

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confidence: 95%

Gastric cancer

Wöll¹

2008

memo

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“…Median overall survival time was 9.4 months for DC and 10.2 months for FLC. DC was associated with more neutropenia while FLC was associated with more GI toxicity [34].…”

Section: Rest Of the Worldmentioning

confidence: 99%

Chemotherapy in the Treatment of Metastatic Gastric Cancer: Is There a Global Standard?

Kang

Kauh

2011

Curr. Treat. Options in Oncol.

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Gastric cancer remains one of the leading causes of cancer mortality worldwide even though its incidence has been decreasing in recent years. Despite remarkable advancements in chemotherapy, advanced gastric cancer has remained a therapeutic challenge for physicians as well as for patients. While early chemotherapeutic regimens succeeded in showing a modest but definite improvement over best supportive care, no single regimen stood out as superior. Most early trials failed to show survival benefit of combination regimens over single agent fluorouracil, but combination regimens were shown to have better response rates. Based on these data, the Japanese adopted single agent fluorouracil as a reference standard for further investigations, while the rest of the world used a doublet containing fluorouracil and platinum. As more clinical trials were conducted, the Japanese standard evolved into a doublet, while the Western countries adopted triplet combinations. There is no established global standard as yet, but with the introduction of newer targeted agents based on molecular assays and personalized approaches combined with conventional chemotherapy, multiple regimens are likely to emerge as global standards rather than one standard treatment for all.

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“…However, the toxicity of this regimen limits its widespread use. Therefore, Ridwelski et al investigated the activity of docetaxel and cisplatin administered on a 3 weekly schedule (without 5-FU) and compared the activity of this regimen with 5-FU and cisplatin in a phase III study [ 62 ]. A total of 273 patients were enrolled, and the primary study endpoint was prolongation of time to progression.…”

Section: Esophagogastric Cancersmentioning

confidence: 99%

Updates in Gastrointestinal Oncology – insights from the 2008 44th annual meeting of the American Society of Clinical Oncology

Javle

Hsueh

2009

J Hematol Oncol

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We have reviewed the pivotal presentations rcelated to colorectal cancer (CRC) and other gastrointestinal malignancies from 2008 annual meeting of the American Society of Clinical Oncology (ASCO). We have discussed the scientific findings and the impact on practice guidelines and ongoing clinical trials. The report on KRAS status in patients with metastatic CRC receiving epidermal growth factor receptor (EGFR) targeted antibody treatment has led to a change in National Comprehensive Cancer Network guideline that recommends only patients with wild-type KRAS tumor should receive this treatment. The results of double biologics (bevacizumab and anti-EGFR antibody) plus chemotherapy as first-line treatment in patients with metastatic CRC has shown a worse outcome than bevacizumab-based regimen. Microsatellite Instability has again been confirmed to be an important predictor in patients with stage II colon cancer receiving adjuvant treatment.Adjuvant gemcitabine therapy for pancreatic cancer was investigated by the CONKO-001 study; this resulted in superior survival as compared with observation and can be regarded as an acceptable option, without the addition of radiotherapy. The addition of bevacizumab to gemcitabine and erlotinib was not supior to gemcitabine and erlotinib for advanced disease. Second-line therapy for advanced pancreatic cancer with 5-fluorouracil and oxaliplatin resulted in a survival benefit. Irinotecan plus cisplatin and paclitaxel plus cisplatin result in similar survival when combined with radiotherapy for esophageal cancer. The novel fluoropyrimidine S1 appears to be active in gastric cancer, as a single agent or as combination therapy. Adjuvant intraperitoneal mitomycin-C may decrease the incidence of peritoneal recurrence of gastric cancer. Sorafenib is an effective agent in Asian patients with hepatocellular carcinoma secondary to hepatitis B; its utility in child's B cirrhosis remains to be proven. Sunitinib is also an active agent in hepatocellular carcinoma, and may represent an alterative to sorafenib for advanced disease. These and other important presentations from the 2008 ASCO annual meeting are discussed in this article.

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Docetaxel-cisplatin (DC) versus 5-fluorouracil-leucovorin-cisplatin (FLC) as first-line treatment for locally advanced or metastatic gastric cancer: Preliminary results of a phase III study

Cited by 13 publications

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Gastric cancer

Gastric cancer

Chemotherapy in the Treatment of Metastatic Gastric Cancer: Is There a Global Standard?

Updates in Gastrointestinal Oncology – insights from the 2008 44th annual meeting of the American Society of Clinical Oncology

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