Table 4.

Details of primary tumor diagnoses, prior palliative treatments, and response data in patients with SCCHN

PatientReovirus doseDisease sitePrevious treatmentsResponse to previous treatmentsNo. of cycles of trial medicationRECIST responseClinical response
01023 × 109OropharynxCDDP/5-FU (6 cycles)CR8NE (assessable disease in previously irradiated region)Major clinical response (complete resolution of cutaneous nodules)
03033 × 1010LarynxCDDP/Cape/Epi (1 cycle)PD2PDN/A
20033 × 1010OropharynxCDDP/5-FU (6 cycles)PR8PRN/A
CDDP/5-FU (6 cycles)PD
Zalutumumab (2 cycles)PD
20043 × 1010HypopharynxCBCDA/5-FU (6 cycles)PD2PDN/A
20063 × 1010LarynxCDDP/5-FU (4 cycles)PR5PRN/A
CDDP/5-FU (2 cycles)PD
20073 × 1010HypopharynxCDDP/5-FU (2 cycles)PD1NE (death due to disease progression before 2 cycles)N/A
20083 × 1010Oral cavityCDDP/5-FU (4 cycles)CR6PRN/A
CDDP/5-FU (4 cycles)PR
CBCDA/5-FU (3 cycles)PD
20113 × 1010OropharynxCDDP/5-FU (6 cycles)PD1NE (death due to disease progression before 2 cycles)N/A
20133 × 1010OropharynxCDDP/5-FU (3 cycles)PD4SDN/A
20143 × 1010OropharynxCDDP/RTPD1NE (treatment stopped because of SAE before 2 cycles)N/A
20153 × 1010Oral cavityCBCDA/Cape (2 cycles)PD6SDN/A
20163 × 1010HypopharynxCDDP/RTPD6NE (assessable disease in previously irradiated region)Major clinical response (complete resolution of skin nodules, Fig. 2I and J)
20183 × 1010OropharynxCDDP/5-FU (6 cycles)PR8SDN/A
20193 × 1010OropharynxCDDP (6 cycles)CR1NE (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.