Table 4.
Patient | Reovirus dose | Disease site | Previous treatments | Response to previous treatments | No. of cycles of trial medication | RECIST response | Clinical response |
---|---|---|---|---|---|---|---|
0102 | 3 × 109 | Oropharynx | CDDP/5-FU (6 cycles) | CR | 8 | NE (assessable disease in previously irradiated region) | Major clinical response (complete resolution of cutaneous nodules) |
0303 | 3 × 1010 | Larynx | CDDP/Cape/Epi (1 cycle) | PD | 2 | PD | N/A |
2003 | 3 × 1010 | Oropharynx | CDDP/5-FU (6 cycles) | PR | 8 | PR | N/A |
CDDP/5-FU (6 cycles) | PD | ||||||
Zalutumumab (2 cycles) | PD | ||||||
2004 | 3 × 1010 | Hypopharynx | CBCDA/5-FU (6 cycles) | PD | 2 | PD | N/A |
2006 | 3 × 1010 | Larynx | CDDP/5-FU (4 cycles) | PR | 5 | PR | N/A |
CDDP/5-FU (2 cycles) | PD | ||||||
2007 | 3 × 1010 | Hypopharynx | CDDP/5-FU (2 cycles) | PD | 1 | NE (death due to disease progression before 2 cycles) | N/A |
2008 | 3 × 1010 | Oral cavity | CDDP/5-FU (4 cycles) | CR | 6 | PR | N/A |
CDDP/5-FU (4 cycles) | PR | ||||||
CBCDA/5-FU (3 cycles) | PD | ||||||
2011 | 3 × 1010 | Oropharynx | CDDP/5-FU (6 cycles) | PD | 1 | NE (death due to disease progression before 2 cycles) | N/A |
2013 | 3 × 1010 | Oropharynx | CDDP/5-FU (3 cycles) | PD | 4 | SD | N/A |
2014 | 3 × 1010 | Oropharynx | CDDP/RT | PD | 1 | NE (treatment stopped because of SAE before 2 cycles) | N/A |
2015 | 3 × 1010 | Oral cavity | CBCDA/Cape (2 cycles) | PD | 6 | SD | N/A |
2016 | 3 × 1010 | Hypopharynx | CDDP/RT | PD | 6 | NE (assessable disease in previously irradiated region) | Major clinical response (complete resolution of skin nodules, Fig. 2I and J) |
2018 | 3 × 1010 | Oropharynx | CDDP/5-FU (6 cycles) | PR | 8 | SD | N/A |
2019 | 3 × 1010 | Oropharynx | CDDP (6 cycles) | CR | 1 | NE (treatment stopped because of SAE before 2 cycles) | N/A |
Methotrexate (4 cycles) | PD |
Abbreviations: 5-FU, 5-fluorouracil; Cape, capecitabine; CBCDA, carboplatin; CDDP, cisplatin; Epi, epirubicin; N/A, not applicable; NE, nonevaluable; PD, progressive disease; PR, partial response; RT, radiotherapy; SAE, serious adverse event; SD, stable disease.