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FDA Expands Indication for Scalp Cooling System to Include All Solid Tumors

Jason Harris
Published: Tuesday, Jun 12, 2018

The FDA has expanded the indication for the Orbis Paxman Hair Loss Cooling System to prevent chemotherapy-related alopecia in patients with solid tumors, device maker Paxman has announced. The system was approved last year to treat chemotherapy-related alopecia in patients with breast cancer.

In the cooling arm, 44.6% of patients used a wig or scarf compared with 68.5% in the control group. Among patients with grade 2 (>50%) hair loss, wig or scarf use was unknown for 20% of patients in the experimental arm versus 31.5% of the control group. No woman in the control group was known to go without a scarf or wig compared with 33.9% of the cooling group.

“This is another step forward in making cancer therapy more personalized and putting the patients in the driver’s seat as we create more options and pathways our patients,” Debu Tripathy, MD, professor and chair of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center, said in a statement.

There was no difference in quality of life scores between the experimental and control arms, or between those who had alopecia and those retained their hair.

All adverse events associated with the cooling system were grade 1/2. Following 4 cycles of chemotherapy, 4.8% of patients experienced headache and 1.2% experienced nausea.  

At this year’s ASCO meeting, investigators presented results from a retrospective analysis of the efficacy and safety of the Paxman system.3 Data from 86 women with primary breast cancer who received neoadjuvant or adjuvant treatment with anthracyclines, taxanes, or both were included in the findings.

All patients received sensor-controlled scalp-cooling (SCSC) treatment during chemotherapy. Investigators assessed chemotherapy-induced alopecia 3 weeks after chemotherapy completion. A quality of hair preservation score of 0 to 2 was considered a success; 3 to 4 was considered a failure.

The success rate for hair preservation was 64%. Thirty-five (40.7%) patients had complete preservation and 20 (23.3%) had partial preservation.

The efficacy of scalp cooling was similar in pre- and postmenopausal women, and for adjuvant and neoadjuvant treatment. However, the success rate for patients assigned to a taxane (80.0%) or a taxane followed by an anthracycline (73.9%) was significantly greater than for those who received an anthracycline followed by a taxane (47.4%; P = .016).

Twenty-seven (31.4%) patients discontinued scalp cooling, with most (24.4%) citing alopecia as the reason. Six patients complained of local discomfort (n = 3; 3.5%) or pain (n = 3; 3.5%).

The Orbis system is the second scalp cooling system granted FDA approval. The agency approved the DigniCap System for patients with breast cancer in December 2015. That indication was expanded to include all solid tumors in 2017.


  1. Nangia JR, Wang T, Osborne CRC, et al. Scalp Cooling Alopecia Prevention trial (SCALP) for patients with early stage breast cancer. J Clin Oncol. 35, 2017 (suppl; abstr 10088).
  2. Nangia JR, Wang T, Osborne CRC, et al. Effect of a scalp cooling device on alopecia in women undergoing chemotherapy for breast cancer: the SCALP randomized clinical trial. JAMA. 2017;317(6):596-605. doi:10.1001/jama.2016.20939.
  3. Kurbacher CM, Herz S, Kurbacher AT, et al. Sensor-controlled scalp cooling for chemotherapy-induced alopecia: Safety and effectiveness in primary breast cancer patients exposed to anthracyclines and/or taxanes in the neoadjuvant or adjuvant setting. J Clin Oncol. 36, 2018 (suppl; abstr e22196).


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