QUALITY OF LIFE ANALYSIS IN THE GALAXY TRIALTM (NCT01348126): A RANDOMIZED PHASE IIB/III STUDY OF GANETESPIB (STA-9090) IN COMBINATION WITH DOCETAXEL VERSUS DOCETAXEL ALONE IN PATIENTS WITH STAGE IIIB OR IV NSCLC

Background

Inhibition of Hsp90, a key molecular chaperone required for activation of many oncoproteins, can lead to cancer cell death. Ganetespib is an Hsp90 inhibitor that has shown single agent activity in patients with NSCLC, breast and gastric cancers. Combination therapy in 2nd line NSCLC has been hampered by enhanced toxicity and negative impact on the patients' quality of life (QoL)

Methods

This randomized trial compares ganetespib (G) + docetaxel (D) to D in 2nd line advanced NSCLC patients. The primary endpoint is progression free survival; secondary endpoints included disease control rate, overall survival and patient-reported outcomes as measured by the QoL Questionnaire using the EORTC QLQ -C30. The questionnaire was completed at 3 time points through the study; at baseline, at weeks 6 and 12 of study treatment. The impact of G on pain, fatigue, and dyspnea were explored. Changes from baseline were calculated at each time point for each domain or symptom.

Results

Approximately 160 of the 300 planned patients were enrolled by early May. Baseline characteristics were balanced. The overall safety profile of the combination is comparable to D arm. QoL in patients treated with D + G was not negatively impacted compared with those receiving D. Analysis of the symptom scale showed a trend towards improvement for pain, fatigue, and appetite loss. There was a marked improvement in dyspnea scale with G + D compared to D. As expected, the functional status was stable and didn't demonstrate significant difference in the QoL deterioration between the 2 treatment arms.

Conclusions

The addition of ganetespib to docetaxel has no negative impact on QoL as assessed by EORTC QLQ -C30

Disclosure

All authors have declared no conflicts of interest.

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