A study of 9-nitrocamptothecin (RFS-2000) in patients with advanced pancreatic cancer.

Stehlin, John S.; Giovanella, Beppino C.; Natelson, Ethan A.; Ipolyi, Peter D. De; Coil, D; Davis, Ben; Wolk, David; Wallace, Patti; Trojacek, A

doi:10.3892/ijo.14.5.821

Cited by 44 publications

(38 citation statements)

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“…Furthermore, the sample size of most series is limited to o20 patients per treatment arm (Oettle et al, 2000;Ulrich-Pur et al, 2003;Milella et al, 2004;Reni et al, 2004), thus producing data with very large CIs. Given these differences, (Kozuch et al, 2001;Ulrich-Pur et al, 2003;Milella et al, 2004) and compares favourably with the 0 -10% objective responses reported elsewhere (Stehlin et al, 1999;Oettle et al, 2000;Ulrich-Pur et al, 2003;Cantore et al, 2004;Reni et al, 2004). The median PFS of 1.8 months observed with TOM-OX regimen was slightly shorter than the median PFS of 1.7 -4.1 months reported in other series (Stehlin et al, 1999;Oettle et al, 2000;Kozuch et al, 2001;Ulrich-Pur et al, 2003;Cantore et al, 2004;Milella et al, 2004;Reni et al, 2004).…”

Section: Discussionmentioning

confidence: 53%

“…As no further standard therapeutic option exists and scarce information on the impact on outcome of salvage therapy is available, prospective trials attempting to widen the therapeutic armamentarium against this disease are warranted. So far, very few studies have investigated salvage chemotherapy after failure of gemcitabine or gemcitabine-containing chemotherapy (Stehlin et al, 1999;Oettle et al, 2000;Ulrich-Pur et al, 2003;Cantore et al, 2004;Milella et al, 2004; Reni et al, 2004), one of which was retrospective (Kozuch et al, 2001). The populations selected were different in terms of proportion of patients with PS480, which ranged from 0 to 61%, metastatic patients (73 -100%), patients with liver metastases (57 -85%), patients with 41 prior chemotherapy lines (0 -29%), and median PFS after previous treatment (6.0 -7.9 months), which was rarely reported in other series, while in our exploratory analyses it resulted as an independent factor predicting the outcome of salvage therapy (Table 6).…”

Section: Discussionmentioning

confidence: 99%

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Raltitrexed–eloxatin salvage chemotherapy in gemcitabine-resistant metastatic pancreatic cancer

Reni¹,

Pasetto²,

Aprile³

et al. 2006

Br J Cancer

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Limited information on salvage treatment in patients affected by pancreatic cancer is available. At failure, about half of the patients present good performance status (PS) and are candidate for further treatment. Patients 418 years, PS X50, with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-containing chemotherapy, and progression-free survival (PFS) o12 months received a combination of raltitrexed (3 mg m À2 ) and oxaliplatin (130 mg m À2 ) every 3 weeks until progression, toxicity, or a maximum of six cycles. A total of 41 patients received 137 cycles of chemotherapy. Dose intensity for both drugs was 92% of the intended dose. Main grade 42 toxicity was: neutropenia in five patients (12%), thrombocytopenia, liver and vomiting in three (7%), fatigue in two (5%). In total, 10 patients (24%) yielded a partial response, 11 a stable disease. Progression-free survival at 6 months was 14.6%. Median survival was 5.2 months. Survival was significantly longer in patients with previous PFS 46 months and in patients without pancreatic localisation. A clinically relevant improvement of quality of life was observed in numerous domains. Raltitrexedoxaliplatin regimen may constitute a treatment opportunity in gemcitabine-resistant metastatic pancreatic cancer. Previous PFS interval may allow the identification of patients who are more likely to benefit from salvage treatment.

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Section: Discussionmentioning

confidence: 53%

Section: Discussionmentioning

confidence: 99%

Raltitrexed–eloxatin salvage chemotherapy in gemcitabine-resistant metastatic pancreatic cancer

Reni¹,

Pasetto²,

Aprile³

et al. 2006

Br J Cancer

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“…Other chemotherapeutic drugs, such as paclitaxel (Oettle et al, 2000), rubitecan (Stehlin et al, 1999), and irofulven (Weitman et al, 2001), a unique cytotoxic agent that is related to the mushroom-derived illudins, unfortunately, are only marginally effective or do not seem to hold their promise (D Von Hoff, personal communications).…”

Section: Discussionmentioning

confidence: 99%

Irinotecan plus raltitrexed vs raltitrexed alone in patients with gemcitabine-pretreated advanced pancreatic adenocarcinoma

et al. 2003

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There is no established second-line treatment for advanced pancreatic cancer after gemcitabine failure. In view of the urgent need for such therapy, and since preclinical and phase I clinical data suggest an encouraging, potentially synergistic activity between raltitrexed and irinotecan, the present randomised phase II study was initiated. A total of 38 patients with metastatic pancreatic adenocarcinoma, who progressed while receiving or within 6 months after discontinuation of palliative first-line chemotherapy with gemcitabine, were enrolled in this study. They were randomised to 3-weekly courses of raltitrexed 3 mg m À2 on day 1 (arm A) or irinotecan 200 mg m À2 on day 1 plus raltitrexed 3 mg m À2 on day 2 (arm B). The primary study end point was objective response, secondary end points included progression-free survival (PFS) and overall survival (OS), as well as clinical benefit response in symptomatic patients (n ¼ 28). In the combination arm, the IRC-confirmed objective response rate was 16% (three out of 19 patients had a partial remission; 95% CI, 3 -40%), which was clearly superior to that in the comparator/control arm with raltitrexed alone, in which no response was obtained. Therefore, the trial was already stopped at the first stage of accrual. Also, the secondary study end points, median PFS (2.5 vs 4.0 months), OS (4.3 vs 6.5 months), and clinical benefit response (8 vs 29%) were superior in the combination arm. The objective and subjective benefits of raltitrexed+irinotecan were not negated by severe, clinically relevant treatment-related toxicities: gastrointestinal symptoms (42 vs 68%), partial alopecia (0 vs 42%), and cholinergic syndrome (0 vs 21%) were more commonly noted in arm B; however, grade 3 adverse events occurred in only three patients in both treatment groups. Our data indicate that combined raltitrexed+irinotecan seems to be an effective salvage regimen in patients with gemcitabine-pretreated pancreatic cancer. The superior response activity, PFS and OS (when compared to raltitrexed), as well as its tolerability and ease of administration suggest that future trials with this combination are warranted.

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“…Palliative chemotherapy options for relapsed disease have minor clinical benefit. Single-agent second-line therapy for metastatic pancreatic cancer following gemcitabine failure has been associated with a median survival of less than 5 months [12].…”

Section: Discussionmentioning

confidence: 99%

“…Evaluations of single-agent gemcitabine or rubitecan salvage therapies for metastatic pancreatic cancer have reported good patient tolerability but median survivals of only 3.85 and 4.7 months, respectively [11,12].…”

Section: Introductionmentioning

confidence: 99%

Irinotecan Combined with Gemcitabine, 5-Fluorouracil, Leucovorin, and Cisplatin (G-FLIP) is an Effective and Noncrossresistant Treatment for Chemotherapy Refractory Metastatic Pancreatic Cancer

et al. 2001

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Background. Single agents have only modest activity as treatment for metastatic pancreatic cancer with response rates of less than 10% and median survivals of less than 6 months. Evaluations of single-agent gemcitabine and rubitecan as second-line treatment for relapsed pancreatic cancer have reported good patient tolerability and median survivals of 3.85 months and 4.7 months, respectively. Regimens incorporating two drugs have demonstrated encouraging activity and clinical impact compared with single-agent therapy. G-FLIP is a regimen designed to incorporate four active single agents into a tolerable and active combination. This analysis is a retrospective evaluation of the efficacy and safety of the G-FLIP regimen as second-line chemotherapy in a series of consecutively treated patients with metastatic pancreatic cancer.Methods. G-FLIP was administered over 48 hours and repeated every 2 weeks. Day 1 treatment consisted of sequentially administered gemcitabine 500 mg/m

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A study of 9-nitrocamptothecin (RFS-2000) in patients with advanced pancreatic cancer.

Cited by 44 publications

References 0 publications

Raltitrexed–eloxatin salvage chemotherapy in gemcitabine-resistant metastatic pancreatic cancer

Raltitrexed–eloxatin salvage chemotherapy in gemcitabine-resistant metastatic pancreatic cancer

Irinotecan plus raltitrexed vs raltitrexed alone in patients with gemcitabine-pretreated advanced pancreatic adenocarcinoma

Irinotecan Combined with Gemcitabine, 5-Fluorouracil, Leucovorin, and Cisplatin (G-FLIP) is an Effective and Noncrossresistant Treatment for Chemotherapy Refractory Metastatic Pancreatic Cancer

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