PMID- 16736001
OWN - NLM
STAT- MEDLINE
DCOM- 20060804
LR  - 20220330
IS  - 0007-0920 (Print)
IS  - 1532-1827 (Electronic)
IS  - 0007-0920 (Linking)
VI  - 94
IP  - 12
DP  - 2006 Jun 19
TI  - Biweekly oxaliplatin, raltitrexed, 5-fluorouracil and folinic acid combination 
      chemotherapy during preoperative radiation therapy for locally advanced rectal 
      cancer: a phase I-II study.
PG  - 1809-15
AB  - Oxaliplatin (OXA), raltitrexed (RTX), 5-fluorouracil (FU) and folinic acid (FA) 
      have shown activity in metastatic colorectal cancer, radioenhancing effect and 
      synergism when combined. We evaluated a chemotherapy (CT) combination of OXA, RTX 
      and FU/FA during preoperative radiotherapy (RT) in locally advanced rectal cancer 
      (LARC) patients. Fifty-one patients with LARC at high risk of recurrence (T4, N+ 
      or T3N0 < or =5 cm from anal verge and/or circumferential resection margin < or 
      =5 mm) received three biweekly courses of CT during pelvic RT (45 Gy). Surgery 
      was planned 8 weeks after CT-RT. Recommended doses (RDs) determined during phase 
      I were utilised in the subsequent phase II trial, where the rate of tumour 
      regression grade (TRG) 1 or 2 was the main end point. No toxic deaths occurred, 
      and severe toxicity was easily managed. In phase II, RDs delivered in 31 patients 
      were OXA 100 mg m(-2) and RTX 2.5 mg m(-2) on day 1, and FU 900 mg m(-2) and LFA 
      250 mg m(-2) on day 2. Main severe toxicities by patients were grade 4 
      neutropenia (23%) and grade 3 diarrhoea (19%). In 71% (95% confidence limits, 
      52-86%) of patients, TRG1 (13) or TRG2 (9) was obtained. All patients are alive 
      and recurrence-free after a median follow-up of 29 months. Combination of OXA, 
      RTX and FU/FA with pelvic RT has an acceptable toxicity and a high clinical 
      activity in LARC and should be studied further in patients at high risk of 
      recurrence.
FAU - Avallone, A
AU  - Avallone A
AD  - Department of Medical Oncology, National Tumour Institute, Naples, Italy. 
      avalloneantonio@libero.it
FAU - Delrio, P
AU  - Delrio P
FAU - Guida, C
AU  - Guida C
FAU - Tatangelo, F
AU  - Tatangelo F
FAU - Petrillo, A
AU  - Petrillo A
FAU - Marone, P
AU  - Marone P
FAU - Cascini, L G
AU  - Cascini LG
FAU - Morrica, B
AU  - Morrica B
FAU - Lastoria, S
AU  - Lastoria S
FAU - Parisi, V
AU  - Parisi V
FAU - Budillon, A
AU  - Budillon A
FAU - Comella, P
AU  - Comella P
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20060530
PL  - England
TA  - Br J Cancer
JT  - British journal of cancer
JID - 0370635
RN  - 0 (Organoplatinum Compounds)
RN  - 0 (Quinazolines)
RN  - 0 (Thiophenes)
RN  - 04ZR38536J (Oxaliplatin)
RN  - FCB9EGG971 (raltitrexed)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adenocarcinoma/*therapy
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/*adverse 
      effects
MH  - Colorectal Neoplasms/*therapy
MH  - Digestive System Surgical Procedures
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Fluorouracil/administration & dosage/adverse effects
MH  - Humans
MH  - Leucovorin/administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - *Neoadjuvant Therapy
MH  - Organoplatinum Compounds/administration & dosage/adverse effects
MH  - Oxaliplatin
MH  - *Preoperative Care
MH  - Quinazolines/administration & dosage/adverse effects
MH  - Thiophenes/administration & dosage/adverse effects
PMC - PMC2361331
EDAT- 2006/06/01 09:00
MHDA- 2006/08/05 09:00
PMCR- 2007/06/19
CRDT- 2006/06/01 09:00
PHST- 2006/06/01 09:00 [pubmed]
PHST- 2006/08/05 09:00 [medline]
PHST- 2006/06/01 09:00 [entrez]
PHST- 2007/06/19 00:00 [pmc-release]
AID - 6603195 [pii]
AID - 10.1038/sj.bjc.6603195 [doi]
PST - ppublish
SO  - Br J Cancer. 2006 Jun 19;94(12):1809-15. doi: 10.1038/sj.bjc.6603195. Epub 2006 
      May 30.