Adjuvant Therapy

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The aims of adjuvant treatment of rectal cancer are reduction of local recurrence and distant failure of disease. Until the end of the 1980s there were discordant data on the real efficacy of post-operative treatments in prolonging disease-free and overall survival in colorectal cancer. In 1990 a NIH Consensus Conference [1] was held to revise the results of recent phase III studies [2-4] (Table 1). The Consensus concluded that in rectal cancer post-operative radio-chemotherapy treatment as delivered in study GISTG 7175 [2] was to be considered standard adjuvant therapy both in stages II and III. This treatment had resulted in a 20% advantage in survival compared to the no-therapy arm patients. Nevertheless the combined radiotherapy plus methyl-CCNU and 5-fluo-rouracil (5-FU) approach caused severe acute enteritis and delayed toxicities such as late enteritis and the onset of acute leukaemias. The Consensus Conference therefore recommended the search for new radiotherapy modalities and less toxic and more efficacious chemotherapy regimens. In the last 10 years two studies have demonstrated that the use of methyl CCNU, a leukaemogenic agent, is not necessary, as it does not add efficacy to the 5-FU only scheme. Furthermore, the NCCTG Intergroup Study 86-47-51 demonstrated that 5-FU continuous infusion is more efficacious than a 5-FU bolus scheme in combination with radiotherapy. No differences in local recurrences and survival have been obtained combining 5-FU with folinic acid (FA) low doses, levamisole, FA plus levamisole or bolus 5-FU alone. Up to now, 5-FU bolus or continuous infusion has been the standard

Table 1. Adjuvant rectal phase III studies before 1990

Study

No. patients

Treatment

DFS

Advantage OS

GITSG 7175

227

Control

-

-

RT

No

No

5-FU+methyl CCNU

No

No

5-FU+methyl CCNU+RT

Yes

Yes

NCCTG 79-47-51

204

RT

No

No

5-FU+methyl CCNU+RT

Yes

Yes

NSABP R01

555

Control

-

-

RT

No

No

MOF

Yes

Yes

Table 2. Adjuvant rectal phase III studies after 1990

Study

No. patients

Treatment

GITSG 7180

210

RT+5^FU RT+MF

NCCTG 86-47-51

453

RT+5^FU (bolus) 5-FU^RT+5^FU (infusion)

INT 0114

1696

RT+5^FU RT+5^FU/LEV RT+5^FU/AF RT+5^FU/AF/LEV

chemotherapy in the combined post-operative treatment of rectal cancer (Table 2) [5-7]. Recently, oxali-platin and irinotecan, two new drugs largely used to treat advanced disease, have obtained positive results in phase III adjuvant treatment trials. In particular, an oxaliplatin-containing regimen (FOLFOX) has allowed at three years of follow up a further 23% reduction in disease-free survival compared to a 5-FU and FA combination (MOSAIC) [8]. This result, the good tolerability of this therapy and the fact that oxaliplatin is a radiosensitiser suggest that a combination of 5-FU, oxaliplatin and radiotherapy might be planned for the high-risk patient.

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