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- W2248291032 abstract "e13616 Background: TH‐302 is essentially inactive in normoxic conditions and is activated in regions of severe hypoxia (<1% O2 saturation), releasing a bromo‐isophosphoramide mustard that alkylates DNA. The epidermis and superficial mucosa contain areas of severe hypoxia; TH‐302 can produce events in these regions that likely represent the local activation of TH‐302. Methods: Tx guidelines to prevent and manage TH‐302‐induced events were empirically developed with research personnel during three phase I/II clinical trials (Table). Results: Dermatologic events associated with TH‐302 in the three trials (n = 355) included rash (41%), stomatitis/mucosal inflammation (33%), hyperpigmentation (14%), hand foot syndrome (7%), and cheilitis (3%). Of these, 7% were grade 3; none were grade 4 or 5. The skin/mucosal events were dose‐proportional, predictable, and reversible. Implementation of tx guidelines decreased the frequency and severity of these events. Conclusions: The tx guidelines allow TH‐302 administration at clinically active doses and should be prospectively investigated in future comparative studies. Toxicity Prophylaxis Grade 1 Grade 2 Grade 3 Intertriginous rash Desitin or zinc oxide cream (40%) BID to perineal area; cool packs to inguinal region during TH‐302 infusion; gentle skin care Preparation‐H to perineal area before infusion + continue prophylaxis + Silvadene 1% cream BID Silvadene 1% cream + triamcinolone 0.1% cream BID Continue grade 2 tx regimen + interrupt TH‐302 until grade 0‐1 Mucositis Oral cryotherapy during TH‐302 infusion Continue prophylaxis + anti‐inflammatory or antibacterial mouthwashes Interrupt TH‐302 until grade 0‐1 + manage oral pain with elixir (hydrocortisone 200 mg, nystatin 2 million units, tetracycline 1500 mg, and Benadryl equal to 250 cc) swish and swallow 1 teaspoon TID and pain control Continue grade 2 tx regimen + reassess pt after 2 weeks Hand‐foot syndrome Ammonium lactate 12% cream or heavy moisturizer BID Continue prophylaxis + cryotherapy to hands/feet Continue prophylaxis + clobetasol 0.05% cream QD Interrupt TH‐302 until grade 0‐1; discontinue prophylaxis; increase clobetasol 0.05% to BID + pain control" @default.
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- W2248291032 date "2011-05-20" @default.
- W2248291032 modified "2023-09-25" @default.
- W2248291032 title "Treatment (Tx) guidelines for skin and mucosal events in patients with solid tumors (pts) receiving TH‐302, a tumor selective, hypoxia‐activated prodrug." @default.
- W2248291032 doi "https://doi.org/10.1200/jco.2011.29.15_suppl.e13616" @default.
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