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Standard vs pH-adjusted and lidocaine supplemented radiocolloid for patients undergoing sentinel-lymph-node mapping and biopsy for early breast cancer (PASSION-P trial): a double-blind, randomised controlled trial
The Lancet Oncology - Online First, 08/07/09

Stojadinovic A et al. - In a trial to compare degree of pain between standard radiocolloid injection and pH-adjusted and lidocaine-supplemented formulations for pts undergoing sentinel-lymph-node (SLN) mapping for breast cancer, it was concluded that for centres that use radiocolloid injections for SLN mapping in pts with early breast cancer, the addition of 1% lidocaine to the radioisotope solution can improve pt comfort, without compromising SLN identification.

Methods

140 pts with early breast cancer were randomly assigned in a 1:1:1:1 fashion to receive the standard topical 4% lidocaine cream and injection of [99mTc]Tc-sulfur colloid (n=35), or to 1 of 3 other study groups: topical placebo cream and injection of Tc-sulfur colloid containing either sodium bicarbonate (n=35), 1% lidocaine (n=35), or sodium bicarbonate and 1% lidocaine (n=35).
The randomisation sequence was computer generated, and all pts and investigators were masked to treatment allocation.
Primary endpoint was pt-reported breast pain immediately after radioisotope injection, using the Wong-Baker FACES pain rating scale and McGill pain questionnaire, analysed in the per-protocol population.

Results

19 of 140 pts enrolled were excluded from analysis: 9 declined study participation or sought care elsewhere, 9 did not undergo SLN mapping because of disease extent or a technical problem, and 1 had unreliable data.
There were no adverse events.
Mean pain scores on the Wong-Baker scale (0—10) were: 6.0 for those who received standard of practice, 4.7 for those who received radiocolloid plus bicarbonate, 1.6 for those who received radiocolloid plus 1% lidocaine, and 1.6 for those who received radiocolloid plus bicarbonate and 1% lidocaine.
Mean pain rating was 17.5 for the standard-of-care group, 15.4 for the sodium bicarbonate group, 4.6 for the 1% lidocaine group, and 3.4 for the sodium bicarbonate plus 1% lidocaine group.
SLN identification rates for each group were: 96% for the standard of care, 97% for sodium bicarbonate, 90% for 1% lidocaine, and 90% for sodium bicarbonate plus 1% lidocaine group.