Evaluation of the mRECIST and α-fetoprotein ratio for stratification of the prognosis of advanced-hepatocellular-carcinoma patients treated with sorafenib.
OBJECTIVE
To compare the assessment of response and prognosis of patients to sorafenib treatment by the Response Evaluation Criteria in Solid Tumors (RECIST), modified RECIST (mRECIST), α-fetoprotein (AFP) and des-γ-carboxy prothrombin (DCP).


METHODS
Sixty-six patients with advanced hepatocellular carcinoma (HCC) treated with sorafenib were enrolled in this retrospective study. The response to treatment was evaluated by RECIST, mRECIST and changes in AFP and DCP.


RESULTS
The median survival time of all patients was 8.6 months. The median time to radiological progression was 3.3 months. The response rates [complete response (CR) + partial response (PR)] by RECIST and mRECIST were 3.0 and 9.0%, respectively, while the disease control rates [CR + PR + stable disease (SD)] were 50 and 50%, respectively. Assessment by mRECIST of overall survival provided a better stratification of the patients according to the response to treatment (p = 0.009) than RECIST (p = 0.09). Assessment of overall survival by a change in AFP ratio of ≤ 1 at 8 weeks was better than that of >1 at 8 weeks (p = 0.002). The DCP ratio was not useful for assessment of overall survival. Multivariate analysis identified mRECIST response (CR + PR + SD; p = 0.001), AFP ratio at 8 weeks (≤ 1; p = 0.046) and Child-Pugh A before treatment (p = 0.012) as significant and independent determinants of survival. The combination of AFP ratio at 8 weeks, assessment by mRECIST and Child-Pugh score before treatment allows stratification of prognosis of patients treated with sorafenib.


CONCLUSIONS
The combination of mRECIST and AFP ratio is useful for the assessment of prognosis of patients with advanced HCC treated with sorafenib.
Department of Medicine and Molecular Science, Division of Frontier Medical Science, Hiroshima University, Japan.
Tomokazu
T
Kawaoka
Hiroshi
H
Aikata
Eisuke
E
Murakami
Takashi
T
Nakahara
Noriaki
N
Naeshiro
Mio
M
Tanaka
Yoji
Y
Honda
Daisuke
D
Miyaki
Yuko
Y
Nagaoki
Shintaro
S
Takaki
Akira
A
Hiramatsu
Koji
K
Waki
Shoichi
S
Takahashi
Kazuaki
K
Chayama
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000627:therapeutic use*; D015415:Biomarkers / Q000378:metabolism; D014408:Biomarkers, Tumor / Q000032:analysis*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D017063:Outcome Assessment, Health Care; D010671:Phenylurea Compounds; D011379:Prognosis; D011498:Protein Precursors / Q000378:metabolism; D011516:Prothrombin / Q000378:metabolism; D011725:Pyridines / Q000627:therapeutic use*; D012189:Retrospective Studies; D000077157:Sorafenib; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D000509:alpha-Fetoproteins / Q000378:metabolism*
D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D015415:Biomarkers; D014408:Biomarkers, Tumor; D010671:Phenylurea Compounds; D011498:Protein Precursors; D011725:Pyridines; D000509:alpha-Fetoproteins; D009536:Niacinamide; C008208:acarboxyprothrombin; D011516:Prothrombin; D000077157:Sorafenib