Form 2023 R2.0: Ovarian Cancer Pre-HSCT Data

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1 Key Fields Sequence Number Date Received: - - CIBMTR Center Number: CIBMTR Recipient ID: Today's Date: - - Date of HSCT for which this form is being completed: - - HSCT type: (check all that apply) Autologous Allogeneic, unrelated Allogeneic, related Syngeneic (identical twin) Product type: (check all that apply) Marrow PBSC Cord blood Other product Specify: If this is a report of a second or subsequent transplant, check here. Disease Assessment at Diagnosis Questions: What was the date of pathologic diagnosis of Ovarian Cancer? What was the stage of ovarian cancer at diagnosis? 3 What was the histology of ovarian cancer at diagnosis? 4 Specify histology: 5 What was the grade of tumor at diagnosis? 0 - boderline malignant 1 - well defferentiated 2 - moderately differentiated poorly differentiated or undifferentiated tumor grade unknown 6 Were any non-contiguous, extra-abdominal sites of metastases present at diagnosis? Unknown Specify site(s) of metastases present at diagnosis: 7 Central nervous system 8 Diaphragm 9 Liver - parenchymal The Medical College of Wisconsin, Inc. All rights reserved. Page 1 / 9

2 10 Liver - surface; omentum; peritoneum 11 Lung 12 Lymph nodes - distant 13 Lymph nodes - regional 14 Mesentery 15 Pelvis 16 Pleura 17 Other site: 18 Specify site: 19 Did the recipient have a family history of cancer in first-degree relatives (parents, siblings, and children) at the time of diagnosis? Unknown 20 Specify the total number of first-degree relatives affected by cancer: Specify the type(s) of cancer experienced by first-degree relatives: 21 Breast cancer 22 Colorectal carcinoma 23 Ovarian cancer 24 Other cancer 25 Specify cancer: 26 Did the recipient have a family history of cancer in second-degree relatives (grandparents, grandchildren, aunts/uncles, nieces/nephews, and half-siblings) at the time of diagnosis? Unknown 27 Specify the total number of second-degree relatives affected by cancer: 28 Breast cancer 29 Colorectal carcinoma 30 Ovarian cancer The Medical College of Wisconsin, Inc. All rights reserved. Page 2 / 9

3 31 Other cancer 32 Specify cancer: Pre-HSCT Treatment for Ovarian Cancer Questions: Was therapy given (including surgery and neoadjuvant therapy) between diagnosis and the start of the preparative regimen? Line of Therapy (1) Questions: Systemic Therapy 35 Date therapy started: Date therapy stopped: Number of cycles 38 Was therapy given prior to any surgery (neoadjuvant)? Number of cycles unknown/not applicable 39 aldesleukin (interleukin-2) IV IP IV & IP route unknown t given Unknown 40 altretamine (Hexalen) IV IP IV & IP route unknown t given Unknown 41 anastrozole (Arimidex) IV IP IV & IP route unknown t given Unknown 42 bevacizumab (Avastin) IV IP IV & IP route unknown t given Unknown 43 capecitabine (Xeloda) IV IP IV & IP route unknown t given Unknown 44 carboplatin (Paraplatin) IV IP IV & IP route unknown t given Unknown 45 cisplatin (CDDP, Platinol) IV IP IV & IP route unknown t given Unknown 46 cyclophosphamide (CTX) IV IP IV & IP route unknown t given Unknown 47 cytarabine (Ara-C, Cytosar-U) IV IP IV & IP route unknown t given Unknown 48 docetaxel (Taxotere) IV IP IV & IP route unknown t given Unknown 49 Doxorubicin (Adriamycin) IV IP IV & IP route unknown t given Unknown 50 Doxorubicin liposomal (Doxil) IV IP IV & IP route unknown t given Unknown 51 epirubicin (Ellence) IV IP IV & IP route unknown t given Unknown The Medical College of Wisconsin, Inc. All rights reserved. Page 3 / 9

4 52 erlotinib (Tarceva) IV IP IV & IP route unknown t given Unknown 53 Etoposide (VP-16, VePesid) IV IP IV & IP route unknown t given Unknown 54 exemestane (Aromasin) IV IP IV & IP route unknown t given Unknown 55 fluorouracil (5-FU, Adrucil) IV IP IV & IP route unknown t given Unknown 56 fulvestrant (Faslodex) IV IP IV & IP route unknown t given Unknown 57 Gemcitabine (Gemzar) IV IP IV & IP route unknown t given Unknown 58 Ifosfamide (Ifex) IV IP IV & IP route unknown t given Unknown 59 imatinib (Gleevec) IV IP IV & IP route unknown t given Unknown 60 interferon-α (Referon-α) IV IP IV & IP route unknown t given Unknown 61 irinotecan (Camptosar) IV IP IV & IP route unknown t given Unknown 62 lapatinib (Tykerb) IV IP IV & IP route unknown t given Unknown 63 letrozole (Femara) IV IP IV & IP route unknown t given Unknown 64 Mitoxantrone (Novantrone) IV IP IV & IP route unknown t given Unknown 65 oxaliplatin (Eloxatin) IV IP IV & IP route unknown t given Unknown 66 paclitaxel (Taxol) IV IP IV & IP route unknown t given Unknown 67 prednisone (Sterapred) IV IP IV & IP route unknown t given Unknown 68 sorafenib (Bayer) IV IP IV & IP route unknown t given Unknown 69 sunitinib (Sutent, SU11248) IV IP IV & IP route unknown t given Unknown 70 tamoxifen (Nolvadex) IV IP IV & IP route unknown t given Unknown The Medical College of Wisconsin, Inc. All rights reserved. Page 4 / 9

5 71 thiotepa (Thioplex) IV IP IV & IP route unknown t given Unknown 72 topotecan (Hycamtin) IV IP IV & IP route unknown t given Unknown 73 vinblastine (Velban, VLB) IV IP IV & IP route unknown t given Unknown 74 vinorelbine (Navelbine) IV IP IV & IP route unknown t given Unknown 75 other therapy IV IP IV & IP route unknown t given Unknown 76 Specify other therapy: 77 Radiation Therapy: 78 Date therapy started: Date therapy stopped: Local/regional 81 Specify total dose cgy (rads) 82 Sites of non-contiguous extra-abdominal metastases 83 Specify total dose cgy (rads) 84 Whole abdominal/pelvic 85 Specify total dose cgy (rads) 86 Intra-abdominal radioactive phosphate (P32) 87 Specify total dose microcuries (µci) 88 Other radiotherapy site 89 Specify other radiation site 90 Specify total dose cgy (rads) 91 Fractionation schedule: single single daily multiple daily other schedule 92 Abdominal Surgery: 93 Date of surgery: Type of abdominal surgery 95 Specify surgery The Medical College of Wisconsin, Inc. All rights reserved. Page 5 / 9

6 96 Best response to line of therapy: complete remission (CR) - disappearance of all target lesions for a period of at least one month complete response with persistent imaging abnormalities of unknown significance (CRU) partial response (PR) - At least 30% decrease in the sum of the longest diameter of measured lesions (target lesions) taking as reference the baseline sum of longest diameters stable disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient to increase to qualify for PD, taking as reference the smallest sum of the longest diameters since the treatment started progressive disease (PD) - At least a 20% increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum of the longest diameters recorded since the treatment started or the appearance of one or more new lesions not assessed (NA) 97 Date response evaluated: Did disease relapse/progress following this line of therapy? 99 Date of relapse/progression: Indicate the WHO sensitivity of the ovarian carcinoma to any chemotherapy administered prior to the preparative regimen: (Response to last chemotherapy given prior to HSCT; chemotherapy must include 2 cycles of treatment given 6 months prior to HSCT) sensitive - 50% reduction in bidimensional diameter of all disease sites with no new sites of disease; and 50% decrease in CA-125, if elevated resistant - <50% reduction in disease or CA-125 elevation with chemotherapy within 6 months of HSCT untreated - includes chemotherapy given more than 6 months prior to HSCT, or fewer than two treatment cycles Unknown 101 Indicate the WHO sensitivity of the ovarian carcinoma to any platinum-containing chemotherapy administered prior to the preparative regimen: (Response to last platinum therapy given prior to HSCT; therapy must include 2 cycles of treatment given 6 months prior to HSCT.) sensitive - response to platinum with 50% reduction in bidimensional diamter of all disease sites with no new sites of disease; and 50% decrease in CA-125, if elevated (Note: a non-response to subsequent non-platinum chemotherapy does not affect designation.) resistant - <50% response to platinum therapy in disease, or <50% decrease in CA-125, or elevation of CA-125, or relapse 6months after last platinum chemotherapy Unknown Imaging and Laboratory Studies Prior to the Start of the Preparative Regimen Questions: CA-125 Known Unknown 103. % of upper limit of normal Specify imaging performed: 104 Bone imaging Specify imaging method: 105 Bone scan 106 Specify results: Normal Abnormal 107 Was tumor present? Unknown The Medical College of Wisconsin, Inc. All rights reserved. Page 6 / 9

7 108 CT imaging method 109 Specify results: Normal Abnormal 110 Was tumor present? 111 MRI imaging method Unknown 112 Specify results: Normal Abnormal 113 Was tumor present? Unknown 114 X-ray imaging method 115 Specify results: Normal Abnormal 116 Was tumor present? 117 Chest x-ray imaging performed Unknown 118 Specify results: Normal Abnormal 119 Unknown 120 CT scan of chest imaging performed 121 Specify results: Normal Abnormal 122 Was tumor present? Unknown 123 CT scan of abdomen imaging performed 124 Specify results: Normal Abnormal 125 Was tumor present? Unknown 126 CT scan of pelvis imaging performed The Medical College of Wisconsin, Inc. All rights reserved. Page 7 / 9

8 127 Specify results: Normal Abnormal 128 Was tumor present? Unknown 129 Head imaging performed 130 CT imaging method 131 Specify results: Normal Abnormal 132 Was tumor present? 133 MRI imaging method Unknown 134 Specify results: Normal Abnormal 135 Was tumor present? 136 PET scan imaging performed Unknown 137 Specify results: Normal Abnormal 138 Was tumor present? Unknown Specify new sites of disease involvement at any time after diagnosis but before the preparative regimen: (If reporting a second or subsequent HSCT, list sites of disease involvement between last HSCT and before the current preparative regimen.) 139 Central nervous system 140 Diaphragm 141 Liver - parenchymal 142 Liver - surface; omentum; peritoneum 143 Lung 144 Lymph nodes - distant The Medical College of Wisconsin, Inc. All rights reserved. Page 8 / 9

9 145 Lymph nodes - regional 146 Mesentery 147 Pelvis 148 Pleura 149 Other site: 150 Specify new site: Disease Status at the Last Assessment Prior to the Preparative Regimen Questions: What was the disease status at the last evaluation prior to the preparative regimen? complete remission (CR) - disappearance of all target lesions for a period of at least one month complete response with persistent imaging abnormalities of unknown significance (CRU) partial response (PR) - At least 30% decrease in the sum of the longest diameter of measured lesions (target lesions) taking as reference the baseline sum of longest diameters stable disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient to increase to qualify for PD, taking as reference the smallest sum of the longest diameters since the treatment started progressive disease (PD) - At least a 20% increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum of the longest diameters recorded since the treatment started or the appearance of one or more new lesions not assessed (NA) 152 Specify reason: 153 Date of the most recent assessment for disease status prior to the preparative regimen: - - First Name: Phone number: Last Name: Fax number: address: The Medical College of Wisconsin, Inc. All rights reserved. Page 9 / 9

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