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Palliative first-line therapy with weekly high-dose 5-fluorouracil and sodium folinic acid as a 24-hour infusion (AIO regimen) combined with weekly irinotecan in patients with metastatic adenocarcinoma of the stomach or esophagogastric junction followed by secondary metastatic resection after downsizing.

Koucky K, Wein A, Konturek PC, Albrecht H, Reulbach U, Männlein G, Wolff K, Ostermeier N, Busse D, Golcher H, Schildberg C, Janka R, Hohenberger W, Hahn EG, Siebler J, Neurath MF, Boxberger F - Med. Sci. Monit. (2011)

Bottom Line: The aim of this retrospective study was to evaluate the efficacy and safety of weekly high-dose 5-fluorouracil (5-FU)/folinic acid (FA) as 24-h infusion (AIO regimen) plus irinotecan in patients with histologically proven metastatic gastroesophageal adenocarcinoma (UICC stage IV).Treatment regimen: irinotecan (80 mg/m²) as 1-h infusion followed by 5-FU (2000 mg/m²) combined with FA (500 mg/m²) as 24-h infusion (d1, 8, 15, 22, 29, 36, qd 57).Combined 5-FU/FA as 24-h infusion plus irinotecan may be considered as an active palliative first-line treatment accompanied by tolerable toxicity; thus offering an alternative to cisplatin-based treatment regimens.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine 1 of Erlangen University, Erlangen, Germany.

ABSTRACT

Background: The aim of this retrospective study was to evaluate the efficacy and safety of weekly high-dose 5-fluorouracil (5-FU)/folinic acid (FA) as 24-h infusion (AIO regimen) plus irinotecan in patients with histologically proven metastatic gastroesophageal adenocarcinoma (UICC stage IV).

Material/methods: From 08/1999 to 12/2008, 76 registered, previously untreated patients were evaluable. Treatment regimen: irinotecan (80 mg/m²) as 1-h infusion followed by 5-FU (2000 mg/m²) combined with FA (500 mg/m²) as 24-h infusion (d1, 8, 15, 22, 29, 36, qd 57).

Results: Median age: 59 years; male/female: 74%/26%; ECOG ≤1: 83%; response: CR: 1%, PR: 16%, SD: 61%, PD: 17%, not evaluable in terms of response: 5%; tumor control: 78%; median OS: 11.2 months; median time-to-progression: 5.3 months; 1-year survival rate: 49%; 2-year survival rate: 17%; no evidence of disease: 6.6%; higher grade toxicities (grade 3/4): anemia: 7%, leucopenia: 1%, ascites: 3%, nausea: 3%, infections: 12%, vomiting: 9%, GI bleeding of the primary tumor: 4%, diarrhea: 17%, thromboembolic events: 4%; secondary metastatic resection after downsizing: 16 patients (21%), R-classification of secondary resections: R0/R1/R2: 81%/6%/13%, median survival of the 16 patients with secondary resection: 23.7 months.

Conclusions: Combined 5-FU/FA as 24-h infusion plus irinotecan may be considered as an active palliative first-line treatment accompanied by tolerable toxicity; thus offering an alternative to cisplatin-based treatment regimens. Thanks to efficient interdisciplinary teamwork, secondary metastatic resections could be performed in 16 patients. In total, the patients who had undergone secondary resection had a median survival of 23.7 months, whereas the median survival of patients without secondary resection was 10.1 months (p≤0.001).

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Multi-layer PET-CT scan with intravenous application of 18fluor-desoxyglucosis (FDG), coronary layers: 67-year-old female patient with multiple intra-thoracic and intra-abdominal lymph node metastases and histologically proven gastric adenocarcinoma. (A) Cervical (white arrow) and paraaortal (white arrowheads) lymph node metastases (M1 LYM) in a representative PET-CT scan prior to initiating chemotherapy treatment; (B) After 3 cycles (6 months) of high-dose 5-FU/FA as 24h-infusion (AIO regimen) plus irinotecan, the PET-CT scan reveals a complete remission (CR) of the cervical and paraaortal lymph node metastases without evidence of vital tumor tissue. Subsequently, an extended gastrectomy including a dissection of the cervical and paraaortal lymph nodes (D3) was performed after tumor downsizing (PR). The histopathological examination of the resected tumor sample revealed both an R0 situation (ypT3, ypN3 (18/38), L1, V0, M0, G3) and a tumor regression of 40%.
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f2-medscimonit-17-5-cr248: Multi-layer PET-CT scan with intravenous application of 18fluor-desoxyglucosis (FDG), coronary layers: 67-year-old female patient with multiple intra-thoracic and intra-abdominal lymph node metastases and histologically proven gastric adenocarcinoma. (A) Cervical (white arrow) and paraaortal (white arrowheads) lymph node metastases (M1 LYM) in a representative PET-CT scan prior to initiating chemotherapy treatment; (B) After 3 cycles (6 months) of high-dose 5-FU/FA as 24h-infusion (AIO regimen) plus irinotecan, the PET-CT scan reveals a complete remission (CR) of the cervical and paraaortal lymph node metastases without evidence of vital tumor tissue. Subsequently, an extended gastrectomy including a dissection of the cervical and paraaortal lymph nodes (D3) was performed after tumor downsizing (PR). The histopathological examination of the resected tumor sample revealed both an R0 situation (ypT3, ypN3 (18/38), L1, V0, M0, G3) and a tumor regression of 40%.

Mentions: Patients (n=16) who had undergone a secondary resection in addition to palliative chemotherapy achieved a significantly longer median survival of 23.7 months (95% CI: 12.5–34.8) compared to patients (n=60) without secondary resection (10.1 months; 95% CI: 7.8–12.5. Log Rank [Mantel Cox]: X2=13.2, d.f.=1, p≤0.001). Median survival (counted from the date of surgery up to the event of death or end of trial) was 17.7 months (95% CI: 10.8–24.6) in the patient group which underwent secondary resection (n=16). Figure 1 presents the Kaplan-Meier curves for median survival of both subgroups and Figure 2 presents the case of 1 of the secondary resected patients.


Palliative first-line therapy with weekly high-dose 5-fluorouracil and sodium folinic acid as a 24-hour infusion (AIO regimen) combined with weekly irinotecan in patients with metastatic adenocarcinoma of the stomach or esophagogastric junction followed by secondary metastatic resection after downsizing.

Koucky K, Wein A, Konturek PC, Albrecht H, Reulbach U, Männlein G, Wolff K, Ostermeier N, Busse D, Golcher H, Schildberg C, Janka R, Hohenberger W, Hahn EG, Siebler J, Neurath MF, Boxberger F - Med. Sci. Monit. (2011)

Multi-layer PET-CT scan with intravenous application of 18fluor-desoxyglucosis (FDG), coronary layers: 67-year-old female patient with multiple intra-thoracic and intra-abdominal lymph node metastases and histologically proven gastric adenocarcinoma. (A) Cervical (white arrow) and paraaortal (white arrowheads) lymph node metastases (M1 LYM) in a representative PET-CT scan prior to initiating chemotherapy treatment; (B) After 3 cycles (6 months) of high-dose 5-FU/FA as 24h-infusion (AIO regimen) plus irinotecan, the PET-CT scan reveals a complete remission (CR) of the cervical and paraaortal lymph node metastases without evidence of vital tumor tissue. Subsequently, an extended gastrectomy including a dissection of the cervical and paraaortal lymph nodes (D3) was performed after tumor downsizing (PR). The histopathological examination of the resected tumor sample revealed both an R0 situation (ypT3, ypN3 (18/38), L1, V0, M0, G3) and a tumor regression of 40%.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3539586&req=5

f2-medscimonit-17-5-cr248: Multi-layer PET-CT scan with intravenous application of 18fluor-desoxyglucosis (FDG), coronary layers: 67-year-old female patient with multiple intra-thoracic and intra-abdominal lymph node metastases and histologically proven gastric adenocarcinoma. (A) Cervical (white arrow) and paraaortal (white arrowheads) lymph node metastases (M1 LYM) in a representative PET-CT scan prior to initiating chemotherapy treatment; (B) After 3 cycles (6 months) of high-dose 5-FU/FA as 24h-infusion (AIO regimen) plus irinotecan, the PET-CT scan reveals a complete remission (CR) of the cervical and paraaortal lymph node metastases without evidence of vital tumor tissue. Subsequently, an extended gastrectomy including a dissection of the cervical and paraaortal lymph nodes (D3) was performed after tumor downsizing (PR). The histopathological examination of the resected tumor sample revealed both an R0 situation (ypT3, ypN3 (18/38), L1, V0, M0, G3) and a tumor regression of 40%.
Mentions: Patients (n=16) who had undergone a secondary resection in addition to palliative chemotherapy achieved a significantly longer median survival of 23.7 months (95% CI: 12.5–34.8) compared to patients (n=60) without secondary resection (10.1 months; 95% CI: 7.8–12.5. Log Rank [Mantel Cox]: X2=13.2, d.f.=1, p≤0.001). Median survival (counted from the date of surgery up to the event of death or end of trial) was 17.7 months (95% CI: 10.8–24.6) in the patient group which underwent secondary resection (n=16). Figure 1 presents the Kaplan-Meier curves for median survival of both subgroups and Figure 2 presents the case of 1 of the secondary resected patients.

Bottom Line: The aim of this retrospective study was to evaluate the efficacy and safety of weekly high-dose 5-fluorouracil (5-FU)/folinic acid (FA) as 24-h infusion (AIO regimen) plus irinotecan in patients with histologically proven metastatic gastroesophageal adenocarcinoma (UICC stage IV).Treatment regimen: irinotecan (80 mg/m²) as 1-h infusion followed by 5-FU (2000 mg/m²) combined with FA (500 mg/m²) as 24-h infusion (d1, 8, 15, 22, 29, 36, qd 57).Combined 5-FU/FA as 24-h infusion plus irinotecan may be considered as an active palliative first-line treatment accompanied by tolerable toxicity; thus offering an alternative to cisplatin-based treatment regimens.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine 1 of Erlangen University, Erlangen, Germany.

ABSTRACT

Background: The aim of this retrospective study was to evaluate the efficacy and safety of weekly high-dose 5-fluorouracil (5-FU)/folinic acid (FA) as 24-h infusion (AIO regimen) plus irinotecan in patients with histologically proven metastatic gastroesophageal adenocarcinoma (UICC stage IV).

Material/methods: From 08/1999 to 12/2008, 76 registered, previously untreated patients were evaluable. Treatment regimen: irinotecan (80 mg/m²) as 1-h infusion followed by 5-FU (2000 mg/m²) combined with FA (500 mg/m²) as 24-h infusion (d1, 8, 15, 22, 29, 36, qd 57).

Results: Median age: 59 years; male/female: 74%/26%; ECOG ≤1: 83%; response: CR: 1%, PR: 16%, SD: 61%, PD: 17%, not evaluable in terms of response: 5%; tumor control: 78%; median OS: 11.2 months; median time-to-progression: 5.3 months; 1-year survival rate: 49%; 2-year survival rate: 17%; no evidence of disease: 6.6%; higher grade toxicities (grade 3/4): anemia: 7%, leucopenia: 1%, ascites: 3%, nausea: 3%, infections: 12%, vomiting: 9%, GI bleeding of the primary tumor: 4%, diarrhea: 17%, thromboembolic events: 4%; secondary metastatic resection after downsizing: 16 patients (21%), R-classification of secondary resections: R0/R1/R2: 81%/6%/13%, median survival of the 16 patients with secondary resection: 23.7 months.

Conclusions: Combined 5-FU/FA as 24-h infusion plus irinotecan may be considered as an active palliative first-line treatment accompanied by tolerable toxicity; thus offering an alternative to cisplatin-based treatment regimens. Thanks to efficient interdisciplinary teamwork, secondary metastatic resections could be performed in 16 patients. In total, the patients who had undergone secondary resection had a median survival of 23.7 months, whereas the median survival of patients without secondary resection was 10.1 months (p≤0.001).

Show MeSH
Related in: MedlinePlus