{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T18:12:00Z","timestamp":1791655920029,"version":"4.3.4"},"reference-count":24,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"21","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2001,11,1]]},"abstract":"<jats:p> PURPOSE: To compare 6% miltefosine solution (Miltex; Asta Medica, Frankfurt, Germany), a new topical cytostatic drug, with placebo as palliative treatment for cutaneous metastases from breast cancer. <\/jats:p><jats:p> PATIENTS AND METHODS: In a double-blind, placebo-controlled, multicenter phase III study, a total of 52 patients with inoperable progressive skin lesions from histologically or cytologically confirmed breast cancer, not manageable by radiotherapy or systemic treatment, with superficial or flat skin lesions (estimated depth of invasion \u2264 1 cm) were randomized to receive either 6% miltefosine solution or placebo. The solution was applied at the dose of 2 drops\/10 cm<jats:sup>2<\/jats:sup>, once daily during the first week and twice daily thereafter until treatment failure. <\/jats:p><jats:p> RESULTS: Treatment groups were well balanced for patient characteristics at study entry except for a small difference in age. Time to treatment failure (TTF), the primary parameter of this study, showed miltefosine solution to be significantly superior to placebo (P = .007); the median TTF in the miltefosine solution group was nearly three times longer than that in the placebo group (56 days v 21 days). The rate of response based on intention to treat patients was 33.3% for miltefosine solution compared with 3.7% for placebo (P = .006). Cutaneous reactions were seen mainly in the miltefosine group, with the type and frequency similar to those observed in previous studies. <\/jats:p><jats:p> CONCLUSION: 6% Miltefosine solution is confirmed as an effective palliative treatment option for cutaneous metastases from breast cancer. Skin reactions, when present, are well tolerated and only occasionally require cessation of treatment. <\/jats:p>","DOI":"10.1200\/jco.2001.19.21.4150","type":"journal-article","created":{"date-parts":[[2017,2,24]],"date-time":"2017-02-24T07:48:49Z","timestamp":1487922529000},"page":"4150-4159","source":"Crossref","is-referenced-by-count":112,"title":["Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of 6% Miltefosine Solution, a Topical Chemotherapy in Cutaneous Metastases From Breast Cancer"],"prefix":"10.1200","volume":"19","author":[{"given":"R.","family":"Leonard","sequence":"first","affiliation":[{"name":"From Western General Hospital, Edinburgh; The Royal Marsden Hospital, London and Surrey; Guys & St Thomas\u2019 Hospital and Saint George\u2019s Hospital, London; and The Royal South Hants Hospital, Southampton, United Kingdom; Academisch Medisch Centrum, Amsterdam, the Netherlands; and Laboratoire Asta Medica, M\u00e9rignac, France."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Hardy","sequence":"additional","affiliation":[{"name":"From Western General Hospital, Edinburgh; The Royal Marsden Hospital, London and Surrey; Guys & St Thomas\u2019 Hospital and Saint George\u2019s Hospital, London; and The Royal South Hants Hospital, Southampton, United Kingdom; Academisch Medisch Centrum, Amsterdam, the Netherlands; and Laboratoire Asta Medica, M\u00e9rignac, France."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"van Tienhoven","sequence":"additional","affiliation":[{"name":"From Western General Hospital, Edinburgh; The Royal Marsden Hospital, London and Surrey; Guys & St Thomas\u2019 Hospital and Saint George\u2019s Hospital, London; and The Royal South Hants Hospital, Southampton, United Kingdom; Academisch Medisch Centrum, Amsterdam, the Netherlands; and Laboratoire Asta Medica, M\u00e9rignac, France."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Houston","sequence":"additional","affiliation":[{"name":"From Western General Hospital, Edinburgh; The Royal Marsden Hospital, London and Surrey; Guys & St Thomas\u2019 Hospital and Saint George\u2019s Hospital, London; and The Royal South Hants Hospital, Southampton, United Kingdom; Academisch Medisch Centrum, Amsterdam, the Netherlands; and Laboratoire Asta Medica, M\u00e9rignac, France."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Simmonds","sequence":"additional","affiliation":[{"name":"From Western General Hospital, Edinburgh; The Royal Marsden Hospital, London and Surrey; Guys & St Thomas\u2019 Hospital and Saint George\u2019s Hospital, London; and The Royal South Hants Hospital, Southampton, United Kingdom; Academisch Medisch Centrum, Amsterdam, the Netherlands; and Laboratoire Asta Medica, M\u00e9rignac, France."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"David","sequence":"additional","affiliation":[{"name":"From Western General Hospital, Edinburgh; The Royal Marsden Hospital, London and Surrey; Guys & St Thomas\u2019 Hospital and Saint George\u2019s Hospital, London; and The Royal South Hants Hospital, Southampton, United Kingdom; Academisch Medisch Centrum, Amsterdam, the Netherlands; and Laboratoire Asta Medica, M\u00e9rignac, France."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Mansi","sequence":"additional","affiliation":[{"name":"From Western General Hospital, Edinburgh; The Royal Marsden Hospital, London and Surrey; Guys & St Thomas\u2019 Hospital and Saint George\u2019s Hospital, London; and The Royal South Hants Hospital, Southampton, United Kingdom; Academisch Medisch Centrum, Amsterdam, the Netherlands; and Laboratoire Asta Medica, M\u00e9rignac, France."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"R1-095345","unstructured":"Donegan  WL,   Perez-Mesa  CM,   Watson  FR:   A biostatistical study of locally recurrent breast carcinoma.  Surg Gynecol Obstet 122:  529,1966-540,"},{"key":"R2-095345","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.1800531020"},{"key":"R3-095345","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(196601)19:1<67::AID-CNCR2820190107>3.0.CO;2-2"},{"key":"R4-095345","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19810501)47:9<2232::AID-CNCR2820470921>3.0.CO;2-R"},{"key":"R5-095345","doi-asserted-by":"publisher","DOI":"10.1097\/00000658-198303000-00007"},{"key":"R6-095345","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199710023371401"},{"key":"R7-095345","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199710023371402"},{"key":"R8-095345","unstructured":"Chauvet  B,   Simon  JM,   Reynaud-Bougnoux  A,  et al:   R\u00e9cidives mammaires apr\u00e8s traitements conservateurs des cancers du sein:  Facteurs pr\u00e9dictifs et signification pronostique.   Bull Cancer (Paris) 77:  193,1990-1205,"},{"key":"R9-095345","doi-asserted-by":"publisher","DOI":"10.1016\/S0959-8049(98)00301-3"},{"key":"R10-095345","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0142(19990115)85:2<437::AID-CNCR23>3.0.CO;2-1"},{"key":"R11-095345","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19890515)63:10<1912::AID-CNCR2820631007>3.0.CO;2-Y"},{"key":"R14-095345","unstructured":"Hilgard  P,   Klenner  T:   Experimental pharmacology of Miltex and its constituents, in Hilgard P, Engel J (eds):  Clinical Aspects of Miltefosine and its Topical Formulation Miltex.   Drugs of Today 30:  3,1994-20,     (suppl B)"},{"key":"R16-095345","unstructured":"Becker  T,   Voegelli  R:   Molecular targets of miltefosine, in Hilgard P, Engel J (eds):  Clinical Aspects of Miltefosine and its Topical Formulation Miltex.   Drugs of Today 30:  5,1994-12,     (suppl B)"},{"key":"R17-095345","unstructured":"\u00dcberall  F,   Oberhuber  H,   Maly  K,  et al:   Hexadecylphosphocholine inhibits inositol phosphate and protein kinase C activity.  Cancer Res 51:  817,1991-812,"},{"key":"R18-095345","doi-asserted-by":"publisher","DOI":"10.1358\/dnp.1999.12.2.604779"},{"key":"R19-095345","doi-asserted-by":"publisher","DOI":"10.1159\/000417989"},{"key":"R20-095345","doi-asserted-by":"crossref","unstructured":"Unger  C,   Peukert  M,   Sindermann  H,  et al:   Hexadecylphosphocholine in the topical treatment of skin metastases in breast cancer patients.  Cancer Treat Rev 17:  43,1990-246,","DOI":"10.1016\/0305-7372(90)90054-J"},{"key":"R21-095345","unstructured":"Clavel  M,   Mauriac  L,   Vennin  P,  et al:   French multicentric phase II study of topically applied miltefosine (hexadecylphosphocholine) in skin metastasized breast cancer:  Preliminary results.   Eur J Cancer 27:  328,1991   (suppl 2, abstr)"},{"key":"R22-095345","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjc.6690184"},{"key":"R23-095345","unstructured":"Khayat  D,   Breau  JL,   Pouillart  P,  et al:   Miltefosine 6% solution (Mil) as a local treatment in cutaneous metastases of breast cancer in patients receiving a concomitant systemic therapy:  Preliminary results.   Proc Am Soc Clin Oncol 12:  62,1993  (abstr)"},{"key":"R24-095345","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/5.suppl_5.38"},{"key":"R26-095345","unstructured":"David  M,   Sindermann  H,   Junge  K,  et al:   Topical treatment of skin metastases with 6% miltefosine solution (Miltex) in patients with breast cancer:  A meta-analysis of 443 patients.   Proc Am Soc Clin Oncol 16:  150a,1997  (abstr 525)"},{"key":"R30-095345","doi-asserted-by":"publisher","DOI":"10.2307\/2531201"},{"key":"R31-095345","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/64.2.191"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.2001.19.21.4150","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T21:46:53Z","timestamp":1653515213000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.2001.19.21.4150"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2001,11,1]]},"references-count":24,"journal-issue":{"issue":"21","published-print":{"date-parts":[[2001,11,1]]}},"alternative-id":["10.1200\/JCO.2001.19.21.4150"],"URL":"https:\/\/doi.org\/10.1200\/jco.2001.19.21.4150","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2001,11,1]]}}}