PMID- 18650196
OWN - NLM
STAT- MEDLINE
DCOM- 20081009
LR  - 20181201
IS  - 1533-0028 (Print)
IS  - 1533-0028 (Linking)
VI  - 7
IP  - 4
DP  - 2008 Jul
TI  - A phase II study of cetuximab/irinotecan in patients with heavily pretreated 
      metastatic colorectal cancer: predictive value of early specific toxicities.
PG  - 273-9
LID - 10.3816/CCC.2008.n.035 [doi]
AB  - BACKGROUND: This study was designed to evaluate the predictive value of early 
      specific toxicities on efficacy of weekly irinotecan/cetuximab administered as 
      salvage therapy in patients with metastatic colorectal cancer (CRC) refractory to 
      oxaliplatin and irinotecan. PATIENTS AND METHODS: Seventy patients received a 
      regimen composed of weekly irinotecan 125 mg/m2 as a 1-hour intravenous infusion 
      and cetuximab 400 mg/m2 infused over 2 hours as the initial dose and 250 mg/m2 
      infused over 1 hour for subsequent administrations. A single treatment cycle was 
      composed of 4 weekly irinotecan infusions followed by 2 weeks of rest. The 
      predictive value of adverse events (AEs) attributable to cetuximab (rash) and 
      major toxicities attributable to irinotecan (gastrointestinal [GI] and 
      hematologic) were observed after the first cycle of treatment and, therefore, 
      correlated to activity and efficacy of cetuximab and weekly irinotecan. RESULTS: 
      Sixty-six of 70 patients received >or= 1 cycle of chemotherapy and were therefore 
      evaluable for response. Overall, toxicity observed was generally mild and 
      manageable. According to an intent-to-treat analysis, a partial response was 
      exhibited in 15.7% of patients, with a median progression-free survival (PFS) and 
      median overall survival time of 4 months and 9 months, respectively. As expected, 
      PFS (P = .01) and median survival (P = .04) correlated strongly with the presence 
      and severity of the rash. Surprisingly, the presence of at least moderate 
      hematologic and GI toxicity was associated with improved PFS (P = .03). 
      CONCLUSION: Our data suggest that irinotecan-induced AEs might predict a better 
      outcome in advanced CRC. This finding would identify a different subset of 
      patients-those likely to benefit from a renewed sensitivity to irinotecan induced 
      by cetuximab.
FAU - Gamucci, Teresa
AU  - Gamucci T
AD  - Department of Medical Oncology, S.S. Trinita Hospital of Sora, Frosinone, Italy.
FAU - Nelli, Fabrizio
AU  - Nelli F
FAU - Cianci, Giovanni
AU  - Cianci G
FAU - Grassi, Giulia
AU  - Grassi G
FAU - Moscetti, Luca
AU  - Moscetti L
FAU - Sperduti, Isabella
AU  - Sperduti I
FAU - Zeuli, Massimo
AU  - Zeuli M
FAU - Cortesi, Enrico
AU  - Cortesi E
FAU - D'Auria, Giuliana
AU  - D'Auria G
FAU - Pollera, Camillo Francesco
AU  - Pollera CF
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PL  - United States
TA  - Clin Colorectal Cancer
JT  - Clinical colorectal cancer
JID - 101120693
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Organoplatinum Compounds)
RN  - 04ZR38536J (Oxaliplatin)
RN  - 7673326042 (Irinotecan)
RN  - PQX0D8J21J (Cetuximab)
RN  - XT3Z54Z28A (Camptothecin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/administration & dosage
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Camptothecin/administration & dosage/analogs & derivatives
MH  - Cetuximab
MH  - Colorectal Neoplasms/*drug therapy/mortality/physiopathology
MH  - Disease Progression
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Irinotecan
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Organoplatinum Compounds/administration & dosage
MH  - Oxaliplatin
MH  - Prognosis
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2008/07/25 09:00
MHDA- 2008/10/10 09:00
CRDT- 2008/07/25 09:00
PHST- 2008/07/25 09:00 [pubmed]
PHST- 2008/10/10 09:00 [medline]
PHST- 2008/07/25 09:00 [entrez]
AID - S1533-0028(11)70431-5 [pii]
AID - 10.3816/CCC.2008.n.035 [doi]
PST - ppublish
SO  - Clin Colorectal Cancer. 2008 Jul;7(4):273-9. doi: 10.3816/CCC.2008.n.035.