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International multicenter randomized phase III study of 1st line erlotinib followed by 2nd line cisplatin + gemcitabine vs. 1st line cisplatin + gemcitabine

followed by 2nd line erlotinib in advanced NSCLC. The TORCH trial

Authors: C.Gridelli1, F.Ciardiello2, R.Feld3, C.Butts4, V.Gebbia5, G.Genestreti6, A.Favaretto7, R.Wierzbicki8, C.Gallo2, F. Perrone9 on behalf of the TORCH Investigators

Reviewed by: Dr. Charles ButtsDate posted: ASCO 2010 Updates – June 15, 2010

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R

Treatment A:

First line Cisplatin + gemcitabine Followed by second line erlotinib at progression

Treatment B:

First line erlotinib followed by Cisplatin + Gemcitabine at progression

NSCLCNo prior chemo

Stage IIIB/IVPS 0,1

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Baseline characteristics (1)

Standard (n=380)

Experimental (n=380)

Country Italy 306 (81%) 306 (81%)

Canada 74 (19%) 74 (19%)

Gender Male 252 (66%) 252 (66%)

Female 128 (34%) 128 (34%)

Age <70 years 361 (95%) 361 (95%)

70 years 19 (5%) 19 (5%)

Median (range) 62 (34-81) 63 (27-79)

Ethnicity East-Asian 12 (3%) 12 (3%)

Other 368 (97%) 368 (97%)

Smoking status Never 79 (21%) 78 (21%)

Former, current smoker 301 (79%) 302 (79%)

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Baseline characteristics (2)

Standard (n=380)

Experimental (n=380)

ECOG PS 0 185 (49%) 197 (52%)

1 195 (51%) 183 (48%)

Stage IIIB 36 (10%) 46 (12%)

IV 344 (90%) 334 (88%)

Histology Adenocarcinoma, BAC 212 (56%) 210 (55%)

Other 168 (44%) 170 (45%)

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RESULTS

Chemo then Erlotinib

Erlotinib then Chemo

p-value

Response Rate (%)

32 % (28% then 7%)

18% (10% then 10%)

.0001

PFS first line (median,

mos) 5.7 m 2.2 m

OS

(median, mos)

12 m 8.5 m 0.002

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STUDY COMMENTARY

• This trial was designed prior to the IPASS results becoming available.

• Patient population was similar to Canadian population with majority being male, 3% Asian, and 20% never smokers

• In an unselected population of Western patients with advanced NSCLC, the standard approach with chemo first followed by erlotinib second is superior to the reverse.

• First line erlotinib results in lower response rates, shorter PFS and shorter OS in this population.

• Overall, severe toxicities were no different.

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BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS

• Platinum based doublet chemotherapy remains standard first line therapy for unselected patients with advanced NSCLC.

• These results compliment and enforce the results of the IPASS trial.

• Patients with advanced NSCLC should not receive first line RGFR TKI without EGFR mutation status being tested.