Randomized phase 3 trial of irinotecan (CPT-11) + 5FU/folinic acid (FA) vs CDDP + 5FU in 1<sup>st</sup>-line advanced gastric cancer patients

Dank, Magdolna; Załuski, J.; Barone, Carlo; Valvere, Vahur; Peschel, C.; Wenczl, M.; Göker, Erdem; Risse, Marie‐Laure; Awad, Lucile; Bugat, R.

doi:10.1200/jco.2005.23.16_suppl.4003

Cited by 74 publications

(52 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The combination regimen of irinotecan (80 mg m À2 ) followed by folinic acid (500 mg m À2 ) and 5-FU (2000 mg m À2 i.v. over 22 h) weekly for 6 weeks also showed 25% of grade 3/4 neutropenia, 5% of febrile neutropenia, and 22% of grade 3/4 diarrhoea in a randomised trial (Dank et al, 2005).…”

Section: Discussionmentioning

confidence: 83%

“…However, Dank et al (2005) reported that irinotecan plus 5-FU/folinic acid showed a trend to TTP superiority, compared with cisplatin and 5-FU, as well as a better safety profile in a randomised phase III trial. And they suggested that irinotecan plus 5-FU/folinic acid Figure 1 Kaplan -Meier curves for time to disease progression and overall survival for intention-to-treat population (n ¼ 41).…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Phase II study of capecitabine and irinotecan combination chemotherapy in patients with advanced gastric cancer

et al. 2006

View full text Add to dashboard Cite

The present study was conducted to evaluate the efficacy and safety of a combination regimen of capecitabine plus irinotecan in patients with advanced gastric cancer. Patients with previously untreated metastatic or recurrent, measurable gastric cancer received oral capecitabine 1000 mg m À2 twice daily from day 1 to 14 and intravenous irinotecan 100 mg m À2 on days 1 and 8, based on a 3-week cycle. Forty-one patients were enrolled in the current study, among whom 38 were assessable for efficacy and 40 assessable for toxicity. Three complete responses and 16 partial responses were confirmed, giving an overall response rate of 46.3%. At a median follow-up of 269 days, the median time to progression and overall survival were 5.1 and 8.6 months, respectively. Grade 3/4 neutropenia occurred in four patients and grade 3 febrile neutropenia was observed in two patients. Grade 3 diarrhoea and grade 2 hand -foot syndrome occurred in six patients and eight patients, respectively. The combination of capecitabine and irinotecan was found to be well tolerated and effective in patients with advanced gastric cancer. Accordingly, this regimen can be regarded as one of first-line treatment options for advanced gastric cancer.

show abstract

Section: Discussionmentioning

confidence: 83%

Section: Discussionmentioning

confidence: 99%

Phase II study of capecitabine and irinotecan combination chemotherapy in patients with advanced gastric cancer

et al. 2006

View full text Add to dashboard Cite

show abstract

“…The response rate and median overall survival seen with irinotecan/FU/LV in these two studies was 42%, 10.7 months and 40%, 11.3 months, respectively, consistent with our findings for irinotecan/capecitabine. Most recently, a phase III trial comparing irinotecan/FU with cisplatin/FU has been presented in abstract form: there was a non-statistically significant trend towards improved time to progression in the irinotecan arm but there was no difference in overall survival; patients randomised to irinotecan/FU experienced less febrile neutropenia, nausea and stomatitis but more diarrhoea than those randomised to cisplatin/ FU (Dank et al, 2005).…”

Section: Discussionmentioning

confidence: 99%

A phase I and II study of 2-weekly irinotecan with capecitabine in advanced gastroesophageal adenocarcinoma

et al. 2006

View full text Add to dashboard Cite

We investigated 2-weekly intravenous irinotecan combined with oral capecitabine in patients with advanced gastroesophageal adenocarcinoma. In phase I, doses were escalated in chemotherapy naïve or pretreated patients to establish maximum tolerated doses (MTD). In phase II, patients were treated at MTD as first-line therapy with the primary end point of RECIST response. Dose levels in phase I were as follows: Level 1: irinotecan 150 mg m À2 on day 1; capecitabine 850 mg m À2 12-hourly on days 1 -9. Level 2: as level 1 but capecitabine 1000 mg m À2 . Level 3: as level 2 but irinotecan 180 mg m À2 . Level 4: as level 3 but capecitabine 1250 mg m À2 . In phase I, 21 patients were entered. Maximum tolerated dose was level 3. Dose-limiting toxicities were lethargy, diarrhoea, vomiting and mucositis. In phase II, 31 patients were entered at level 3. During the first six cycles, 13 of these patients underwent dose reduction and three patients stopped treatment for toxicity. A further six patients stopped for progressive disease. The commonest grade 3 -4 toxicities were lethargy (20%), diarrhoea (17%), nausea (10%) and anorexia (10%). There were no treatment-related deaths. The response rate was 32% (95% CI 16 -52%). Median overall survival was 10 months. This regimen is active in gastroesophageal adenocarcinoma. However, using the MTD defined in phase I, fewer than 50% patients tolerated six cycles without modification in phase II; therefore, modification of these doses is recommended for further study.

show abstract

“…The overall response rate of 45.7%, median TTP of 4.5 months and OS of 8.2 months were comparable with previously published regimens, most of which are cisplatin-based. (Roth et al, 2000;Kettner et al, 2001;Ridwelski et al, 2001;Ajani et al, 2002;Lim et al, 2003;Pozzo et al, 2004;Ajani et al, 2005;Dank et al, 2005;Moiseyenko et al, 2005). The administration of docetaxel-irinotecan every 3 weeks was performed as first-line chemotherapy for this disease with response rate of 37.5% (Hawkins et al, 2003).…”

Section: Discussionmentioning

confidence: 99%

“…Cisplatin-containing regimens have shown grade 3/4 neutropenia, febrile neutropenia/infection with neutropenia and diarrhoea in 27 -87%, 2 -30% and 5 -22% of patients, according to the published literature. On the other hand, compared with cisplatin-containing regimens, docetaxel/irinotecan combination was associated with a lower incidence of grade 2 or higher neurotoxicity (2.1 vs 2.0-30.8%) and all grade ototoxicity (0 vs 52.7%) (Roth et al, 2000;Kettner et al, 2001;Ridwelski et al, 2001;Ajani et al, 2002;Lim et al, 2003;Pozzo et al, 2004;Ajani et al, 2005;Dank et al, 2005;Moiseyenko et al, 2005). In addition, this regimen did not resulted in any grade of nephrotoxicity.…”

Section: Discussionmentioning

confidence: 99%

Phase II study of docetaxel and irinotecan combination chemotherapy in metastatic gastric carcinoma

Park

Chun

et al. 2006

Br J Cancer

View full text Add to dashboard Cite

The current treatment for metastatic gastric cancer (MGC) consists of cisplatin and/or fluorouracil (5-FU) based combination chemotherapy, but cisplatin-based regimens are associated with considerable toxicity. We evaluated the efficacy and safety of a noncisplatin-, non-5-FU-containing regimen, docetaxel/irinotecan in MGC. Chemo-naive patients with MGC received docetaxel (30 mg m À2 ) and irinotecan (70 mg m À2 ) on days 1 and 8 every 3 weeks. The 48 eligible patients (median age 56 years) received a median of four cycles of docetaxel/irinotecan (range 1 -18). Of the 46 patients in whom efficacy could be evaluated, 21 showed a partial response (response rate ¼ 45.7%; 95% confidence interval (CI) 31.3 -60.1%). At a median follow-up of 15.0 months, the median time to progression was 4.5 months (95% CI 3.8 -5.2 months) and overall survival was 8.2 months (95% CI, 5.8 -10.6 months). Grade 3/4 neutropenia developed in 57.4% of patients, and febrile neutropenia/neutropenic infection in 19.1%. Nonhaematological toxicities were moderate; grade 3/4 diarrhoea occurred in 19.1% of patients, however, was manageable by a dose reduction. There was one possible treatment-related death. In conclusion, weekly docetaxel/irinotecan is a promising outpatient regimen in MGC, with appropriate dose modification.

show abstract

Randomized phase 3 trial of irinotecan (CPT-11) + 5FU/folinic acid (FA) vs CDDP + 5FU in 1^st-line advanced gastric cancer patients

Cited by 74 publications

References 0 publications

Phase II study of capecitabine and irinotecan combination chemotherapy in patients with advanced gastric cancer

Phase II study of capecitabine and irinotecan combination chemotherapy in patients with advanced gastric cancer

A phase I and II study of 2-weekly irinotecan with capecitabine in advanced gastroesophageal adenocarcinoma

Phase II study of docetaxel and irinotecan combination chemotherapy in metastatic gastric carcinoma

Contact Info

Product

Resources

About

Randomized phase 3 trial of irinotecan (CPT-11) + 5FU/folinic acid (FA) vs CDDP + 5FU in 1st-line advanced gastric cancer patients

Cited by 74 publications

References 0 publications

Phase II study of capecitabine and irinotecan combination chemotherapy in patients with advanced gastric cancer

Phase II study of capecitabine and irinotecan combination chemotherapy in patients with advanced gastric cancer

A phase I and II study of 2-weekly irinotecan with capecitabine in advanced gastroesophageal adenocarcinoma

Phase II study of docetaxel and irinotecan combination chemotherapy in metastatic gastric carcinoma

Contact Info

Product

Resources

About

Randomized phase 3 trial of irinotecan (CPT-11) + 5FU/folinic acid (FA) vs CDDP + 5FU in 1^st-line advanced gastric cancer patients