IASLC Mesothelioma Staging Project - Reduced Set of Data Elements for Proposals for Change to 8th Edition TNM 7/7/2013

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1 Page 1 of 16 Patient Characteristics form (3 variables) Disease Description form (6 variables) Pre-treatment/Evaluative TNM form - Pre-Treatment/Evaluative Thickness and Effusions form - Pre-Treatment/Evaluative Invasion form - Pre-Treatment/Evaluative N form - Pre-Treatment/Evaluative M form Treatment form (15 variables) Post-surgical TNM form - Post-Surgical Invasion form - Post-Surgical N form - Post-Surgical M form Follow Up form

2 Page of 16 Patient Characteristics and Disease Description forms Field # Field Name Oracle column Length 1 Patient birth date BIRTHDATE DDMMMYYYY Values/Notes DDD: in (JAN, FEB, MAR, APR, MAY, JUN, JUL, AUG, SEP, OCT, NOV, DEC) Sites may elect to provide only year of birth - or, provide the age at diagnosis in lieu of birth year -- if this is a requirement for release of the data by the local ethics review board. Substituting age at diagnosis for birth date or year is not advisable for sites which intend to export and analyze their data locally. Sex SEX 1 No selection=null, Male=M, Female=F, No data=u 3 Race RACE No selection=null, Asian=ASIAN, Black or African American=BLACK, White 7 or Caucasian=WHITE, American Indian/Alaskan Native/Pacific Islander=PACIFIC, Other/Mixed/Uncertain=UNKNOWN 4 Laterality LATERALITY No selection=null, Right=R, Left=L, Bilateral=BI, No data=nd Histologic No selection=null, Diffuse malignant mesothelioma: Epithelioid Type/Subtype mesothelioma=dmmepi, Diffuse malignant mesothelioma: Sarcomatoid (*Note: If value is mesothelioma=dmmsarc, Diffuse malignant mesothelioma: Desmoplastic 'Other' or 'No mesothelioma=dmmdesmo, Diffuse malignant mesothelioma: Biphasic data', then the mesothelioma=dmmbi, Diffuse malignant mesothelioma: NOS=DMMNOS, following error Localized malignant mesothelioma: Epithelioid mesothelioma=lmmepi, messages is Localized malignant mesothelioma: Sarcomatoid displayed: Cases mesothelioma=lmmsarco, Localized malignant mesothelioma: for which the Desmoplastic mesothelioma=lmmdesmo, Localized malignant histologic type is mesothelioma: Biphasic mesothelioma=lmmbi, Localized malignant specified as mesothelioma: NOS=LMMNOS, Well differentiated papillary 'Other' or for mesothelioma=wdpm, Malignant mesothelioma, NOS=MMNOS, which no Other=OTH, No data=nd histologic type is

3 Page 3 of 16 Patient Characteristics and Disease Description forms Field # 6 7 Field Name Other histologic type Localized vs diffuse? 8 Pleomorphic? 9 Date of pathologic diagnosis % Oracle column OTHERHISTO TYPE LOCALVSDIFF USE PLEOMORPH IC DATEDX Length 100 alphanumeric 9 No selection=null, Localized=L, Diffuse=D, No data=nd, Not applicable=na No selection=null, Yes=Y, No=N, No data=nd Derived variable, format DDMMMYYYY Values/Notes "Other histologic type" entered if Histologic Type/Subtype is 'Malignant mesothelioma, NOS' or 'Other' "Localized vs diffuse" entered if Histologic Type/Subtype is 'Malignant mesothelioma, NOS' or 'Other' % Date of diagnosis is a derived variable which is equal to: 1) the date of histology if histologic proof of malignancy is obtained or ) the date of cytology, if the diagnosis is based on solely on cytologic proof of malignancy. The data contributor may elect to provide year only for the date of diagnosis and to provide "delta times" (days elapsed since the date of diagnosis) for all other date fields.

4 Page 4 of 16 Pre-treatment/Evaluative TNM form Oracle Field # Field Name column Length 10 T Status TSTATUS 5 Values/Notes No selection=null, T1a=TIa, T1b=T1b, T1, NOS=T1NOS, T=T, T3=T3, T4=T4, No data=nd 11 N Status NSTATUS No selection=null, N0=N0, N1=N1, N=N, N3=N3, Nx=NX, No data=nd 1 M Status MSTATUS No selection=null, M0=M0, M1=M1, No data=nd 13 Stage STAGE NULL (if TNM form not submitted), IA=1A, IB=1B, 1=I, II=, 3=III, 4=IV, X=Unable to assess, Post-surgical TNM form Field # Field Name Oracle column Length Values/Notes 14 T Status PTSTATUS 5 No selection=null, T0=T0, T1a=TIa, T1b=T1b, T1, NOS=T1NOS, T=T, T3=T3, T4=T4, Tx=TX, No data=nd 15 N Status PNSTATUS No selection=null, N0=N0, N1=N1, N=N, N3=N3, Nx=NX, No data=nd 16 M Status PMSTATUS No selection=null, M0=M0, M1=M1, No data=nd 17 Stage PSTAGE NULL (if TNM form not submitted), IA=1A, IB=1B, 1=I, II=, 3=III, 4=IV, X=Unable to assess,

5 Page 5 of 16 Pre-Treatment/Evaluative Thickness and Effusions form Field # Field Name Oracle column Le ngth Values/Notes 18 Pleural Thickening PTHICKENING No selection=null, Minimal=MIN, Rind-like=RIND, 4 Nodular=NOD, No data=nd 19 Pleural Plaques PPLAQUES No selection=null, Yes, non-calcified=ncal, Yes, 4 calcified=cal, Yes, calcification not specified=y, No data=nd Measured - Upper level 0 PTUPPER of pleura? 1 Not checked=y, checked=n Maximum thickness - 1 Upper level of pleura PTUPPERSIZE Measured - Middle level of pleura? PTMID 1 Not checked=y, checked=n Maximum thickness - 3 Middle level of pleura PTMIDSIZE Measured - Lower level 4 PTLOWER of pleura? 1 Not checked=y, checked=n Maximum thickness - 5 Lower level of pleura PTLOWERSIZE Pleural effusion PLEUREFF No selection=null, None=NONE; Present, right side=r; 4 Present,left side=l; Present, both sides=both, Present, side not specified=y; No data=nd 7 Cytology (if present) PLEURCYT No selection=null, Positive=POS, Negative=NEG, No 3 data=nd 8 Pericardial effusion PERIEFF No selection=null, No=N; Yes, with positive 4 cytology=ypos; Yes, with negative cytology=yneg; Yes, without cytology results=y; No data=nd

6 Page 6 of 16 IASLC M Pre-Treatment/Evaluative Invasion form Field Oracle column Field Name # Length Values/Notes 9 Ipsilateral Parietal Pleural Invasion PPLEURA No selection=null, N=No, Yes=Y, No data=nd 30 Ipsilateral Visceral Pleural Invasion 31 Fissural Involvement VPLEURA FISSURE No selection=null, N=No, Yes=Y, No data=nd No selection=null, N=No, Yes=Y, No data=nd "Fissural involvement" entered if Visceral Pleural Invasion='Yes' 3 Single focus vs confluent CONFLUENT No selection=null, Single focus=n, Confluent tumor=y, No data=nd "Single focus vs confluent" entered if Visceral Pleural Invasion='Yes' 33 Chest Wall / Endothoracic Fascia Invasion CHESTWALL 5 34 Extent of Chest Wall / Endothoracic Fascia Invasion CHESTWALLEXT 4 No selection=null, No=N, Pleura and endothoracic fascia only=y1, Fascia and chest wall muscle=y; Fascia, chest wall muscle, and ribs=y3, Yes, no further data=y; No data=nd No selection=null, None=NONE, Single focus=y1, Diffuse or multifocal=y; Yes, no further data=y; No data=nd "Extent " entered if Chest Wall / Endothoracic Fascia Invasion = 'Pleura and endothoracic fascia only' or 'Fascia and chest wall muscle' or 'Fascia, chest wall muscle, and ribs' 35 Brachial Plexus Nerve Invasion BRACHPLEX No selection=null, No=N, Yes=Y, No data=nd Contralateral Pleural Invasion (Direct 36 Extension) CONTPLEURA No selection=null, N=No, Yes=Y, No data=nd 37 Lung Parenchyma Invasion LUNGPARENCH No selection=null, No=N, Yes=Y, No data=nd 38 Mediastinal Invasion MEDIASTINUM No selection=null, No=N, Mediastinal fat=y1, Mediastinal organs=y, No data=nd 39 Pericardial Invasion PERICARDIUM No selection=null, No=N, Possible=P, Yes=Y, No data=nd 40 Heart Muscle Invasion HEARTMUSCLE No selection=null, No=N, Yes=Y, No data=nd 41 Oesophageal Invasion ESOPHAGUS No selection=null, No=N, Yes=Y, No data=nd 4 Diaphragm Invasion DIAPHRAGM No selection=null, No=N, Possible=POSS, Probable=PROB, 5 Definite=DEF, Transmural=TRSM, No data=nd 43 Spinal Invasion SPINE No selection=null, No=N, Yes=Y, No data=nd

7 Page 7 of 16 Pre-Treatment/Evaluative N form Field # Field Name Oracle column Length Values 44 Nodal map used: NODALMAP No selection = NULL, IASLC-009 = IASLC, 5 None = NONE, No data = ND 45 Low cervical, supraclavicular and sternal notch, Station #1R IN1R 3 46 Low cervical, supraclavicular and sternal notch, Station #1L IN1L 3 47 Upper paratracheal, Station #R INR 3 48 Upper paratracheal, Station #L INL 3 49 Pre-vascular, Station #3AR IN3AR 1 50 Pre-vascular, Station #3AL IN3AL 1 51 Retrotracheal, Station #3P IN3P 1 5 Lower paratracheal, Station #4R IN4R 1 53 Lower paratracheal, Station #4L IN4L 1 54 Sub-aortic, Station #5 IN Para-aortic, Station #6 IN Subcarinal, Station #7 IN Paraoesophageal, Right, Station #8R IN8R 3 58 Paraoesophageal, Left, Station #8L IN8L 3 59 Pulmonary ligament, Right, Station #9R IN9R 3 60 Pulmonary ligament, Left, Station #9L IN9L 3 61 Hilar, Right, Station #10R IN10R 3 No data = ND, 6 Hilar, Left, Station #10L IN10L 3 + = POS, 63 Interlobar, Right, Station #11R IN11R 3 - = NEG 64 Interlobar, Left, Station #11L IN11L 3 65 Lobar, Right, Station #1R IN1R 3 66 Lobar, Left, Station #1L IN1L 3 67 Segmental, Right, Station #13R IN13R 3 68 Segmental, Left, Station #13L IN13L 3 69 Subsegmental, Right, Station #14R IN14R 3 70 Subsegmental, Left, Station #14L IN14L 3 71 Internal Mammary, Right ININTMAMMARYR 3 7 Internal Mammary, Left ININTMAMMARYL 3 73 Pericardial, Right INPERICARDIALR 3 74 Pericardial, Left INPERICARDIALL 3 75 Peridiaphragmatic, Right INPERIDIAPGHRR 3 76 Peridiaphragmatic, Left INPERIDIAPGHRL 3 77 Intercostal, Right ININTERCOSTALR 3 78 Intercostal, Left ININTERCOSTALL 3 79 Retrocrual, Right INRETROCRUALR 3 80 Retrocrual, Left INRETROCRUALL 3

8 Page 8 of 16 Pre-Treatment/Evaluative M form Field # Field Name Oracle column Length Values Notes 81 Contralateral pleura METPLEURA 8 Contralateral lung METLUNG 83 Peritoneum METPERITONEUM 84 Intra-abdominal METINTRAABDOM 85 Bone METBONE 6 86 Liver parenchyma METLIVER 87 Brain METBRAIN 88 Other distant lymph nodes METOTHERDLN 89 Contralateral pleura - Biopsied or resected METPLEURABX 90 Contralateral lung - Biopsied or resected METLUNGBX 91 Peritoneum - Biopsied or resected METPERITONEUMBX 9 Intra-abdominal - Biopsied or resected METINTRAABDOMBX 93 Bone - Biopsied or resected METBONEBX 6 94 Liver parenchyma - Biopsied or resected METLIVERBX 95 Brain - Biopsied or resected METBRAINBX 96 Other distant lymph nodes - Biopsied or resected METOTHERDLNBX 97 Specify, Other distant sites SPECIFYODSITES 00 alphanumeric 98 Other metastasis OTHERMETASTASIS 00 No selection=null, Absent=ABSENT, Single=SINGLE, Multiple=MULT, Present=PRES, No data=nd No selection=null, Yes, resected=yres; Yes, biopsied, positive for malignancy=ybxpos; Yes, biopsied, negative for malignancy=ybxneg; No=N, No data=nd (optional additional information, when site of lesion is: SINGLE, MULT, or PRES) alphanumeric Document presence, number of lesions, clinical certainty factor, and whether biopsied/resected for any other sites of metastasis not listed above

9 Page 9 of 16 Treatment form Field # Field Name Oracle column Length Values Notes No selection=null; No data=nd -> if 'None' or 'No data' is selected, skip to First Treatment in Sequence None=NONE; IF TREATMENT(FINALPROC) in ('NONE') - only Pre-Surgical forms are applicable 99 Final surgical procedure FINALPROC 1 Exploration, no pleurodesis (no resection)=exp; Exploration, pleurodesis only (no resection)=exppleurod Partial pleurectomy=ppleur; Pleurectomy /decortication=pd; Extended pleurectomy /decortication=extpd; Extrapleural pneumonectomy=epp; IF TREATMENT(FINALPROC) in ('EXP' 'EXPPLEUROD' 'PPLEUR' 'PD' 'EXTPD' 'EPP' 'OTHER') - Both Pre and Post-Surgical forms are applicable Other=OTHER; 100 Date of final procedure OPDATE DDMMMYYYY 101 Surgical approach (final procedure) SRGAPPROACH 5 No selection=null, None=NONE, Median Sternotomy=STERN, Thoracotomy=THOR, VATS=VATS, No data=nd 10 Diaphragm resected? RES_DIAPH 103 Diaphragm reconstructed? RECON_DIAPH 104 Pericardium resected? RES_PERI No selection=null, Yes=Y, No=No, 105 Pericardium reconstructed? RECON_PERI No data=nd 106 Chest wall resected? RES_CW 107 Chest wall reconstructed? RECON_CW DDD in (JAN, FEB, MAR, APR, MAY, JUN, JUL, AUG, SEP, OCT, NOV, DEC)

10 Page 10 of 16 Treatment form Oracle column Field # Field Name Length Values Notes 108 Other ipsilateral lung resection OTHRESECT 5 No selection=null, None=NONE, Segmentectomy=SEG, Wedge Resection=WEDGE, Lobectomy=LOBE, Bilobectomy=BILO, Pneumonectomy=PNEU, Other=OTH, No data=nd No selection=null, R1 (Microscopic residual 109 Completeness of resection RESCOMP tumor)=r1, R (Macroscopic residual tumour)=r, No data=nd Completeness of resection is entered if any of the following conditions are met: 1) Final procedure is not in (Select, None, No data) ) Diaphragm, pericardium, or chest wall is resected 3) Other ipsilateral lung resection is not in (Select, None, No data) 110 First treatment in sequence TRT Second treatment in sequence TRT 5 No selection=null, Surgery=SURG, Systemic therapy=sys, Radiation therapy=rt, Radiation and systemic therapy=rtsys, None=NONE, No data=nd 11 Third treatment in sequence TRT Total dose radiation (Gy) TOTRAD 4 Integer, RT data collected only if RT or RTSYS is indicated as first, second, or third treatment in sequence

11 Page 11 of 16 Post-Surgical Invasion form Field Oracle column Field Name # Length Values/Notes 114 Ipsilateral Parietal Pleural Invasion P_PPLEURA No selection=null, N=No, Yes=Y, No data=nd 115 Ipsilateral Visceral Pleural Invasion 116 Fissural Involvement PVPLEURA PFISSURE No selection=null, N=No, Yes=Y, No data=nd No selection=null, N=No, Yes=Y, No data=nd "Fissural involvement" entered if Visceral Pleural Invasion='Yes' 117 Single focus vs confluent PCONFLUENT No selection=null, Single focus=n, Confluent tumor=y, No data=nd "Single focus vs confluent" entered if Visceral Pleural Invasion='Yes' 118 Chest Wall / Endothoracic Fascia Invasion PCHESTWALL Extent of Chest Wall / Endothoracic Fascia Invasion PCHESTWALLEXT 4 No selection=null, No=N, Pleura and endothoracic fascia only=y1, Fascia and chest wall muscle=y; Fascia, chest wall muscle, and ribs=y3, Yes, no further data=y; No data=nd No selection=null, None=NONE, Single focus=y1, Diffuse or multifocal=y; Yes, no further data=y; No data=nd "Extent " entered if Chest Wall / Endothoracic Fascia Invasion = 'Pleura and endothoracic fascia only' or 'Fascia and chest wall muscle' or 'Fascia, chest wall muscle, and ribs' 10 Brachial Plexus Nerve Invasion PBRACHPLEX No selection=null, No=N, Yes=Y, No data=nd Contralateral Pleural Invasion (Direct 11 Extension) PCONTPLEURA No selection=null, N=No, Yes=Y, No data=nd 1 Lung Parenchyma Invasion PLUNGPARENCH No selection=null, No=N, Yes=Y, No data=nd 13 Mediastinal Invasion PMEDIASTINUM No selection=null, No=N, Mediastinal fat=y1, Mediastinal organs=y, No data=nd 14 Pericardial Invasion PPERICARDIUM No selection=null, No=N, Yes, non-transmural=y1, Yes, transmural=y, Yes, no further data=y, No data=nd. 15 Heart Muscle Invasion PHEARTMUSCLE No selection=null, No=N, Yes=Y, No data=nd 16 Oesophageal Invasion PESOPHAGUS No selection=null, No=N, Yes=Y, No data=nd

12 Page 1 of 16 Post-Surgical Invasion form Field # Field Name Oracle column Length 17 Diaphragm Invasion PDIAPHRAGM 5 Values/Notes No selection=null, No=N, Y1MUSCLE=Muscle only; YPERIT=Muscle plus adjacent peritoneum; Y3ABDOM=Muscle plus adjacent peritoneum plus adjacent abdominal organ, Y4DIFFUSE=Muscle plus diffuse peritoneal, no ascites; Y5ASCITES=Muscle plus diffuse peritoneal with ascites; Y=Yes, no further data, No data=nd. 18 Spinal Invasion PSPINE No selection=null, No=N, Yes=Y, No data=nd 19 Pleural effusion PPLEUREFF No selection=null, None=NONE; Present, right side=r; Present,left 4 side=l; Present, both sides=both, Present, side not specified=y; No data=nd 130 Cytology (if present) PPLEURCYT 3 No selection=null, Positive=POS, Negative=NEG, No data=nd 131 Pericardial effusion PPERIEFF 4 No selection=null, No=N; Yes, with positive cytology=ypos; Yes, with negative cytology=yneg; Yes, without cytology results=y; No data=nd

13 Page 13 of 16 Post-Surgical N form Field # Field Name Oracle column Length Values 13 Nodal map used: PNODALMAP No selection = NULL, IASLC-009 = IASLC, 5 None = NONE, No data = ND 133 Low cervical, supraclavicular and sternal notch, Station #1R PN1R Low cervical, supraclavicular and sternal notch, Station #1L PN1L Upper paratracheal, Station #R PNR Upper paratracheal, Station #L PNL Pre-vascular, Station #3AR PN3AR Pre-vascular, Station #3AL PN3AL Retrotracheal, Station #3P PN3P Lower paratracheal, Station #4R PN4R Lower paratracheal, Station #4L PN4L 3 14 Sub-aortic, Station #5 PN Para-aortic, Station #6 PN Subcarinal, Station #7 PN Paraoesophageal, Right, Station #8R PN8R Paraoesophageal, Left, Station #8L PN8L Pulmonary ligament, Right, Station #9R PN9R Pulmonary ligament, Left, Station #9L PN9L Hilar, Right, Station #10R PN10R 3 No data = ND, 150 Hilar, Left, Station #10L PN10L 3 + = POS, 151 Interlobar, Right, Station #11R PN11R 3 - = NEG 15 Interlobar, Left, Station #11L PN11L Lobar, Right, Station #1R PN1R Lobar, Left, Station #1L PN1L Segmental, Right, Station #13R PN13R 3

14 Page 14 of 16 Post-Surgical N form Field # Field Name Oracle column Length Values 156 Segmental,, Left, Station #13L PN13L Subsegmental, Right, Station #14R PN14R Subsegmental, Left, Station #14L PN14L Internal Mammary, Right PNINTMAMMARYR Internal Mammary, Left PNINTMAMMARYL Pericardial, Right PNPERICARDIALR 3 16 Pericardial, Left PNPERICARDIALL Peridiaphragmatic, Right PNPERIDIAPGHRR Peridiaphragmatic, Left PNPERIDIAPGHRL Intercostal, Right PNINTERCOSTALR Intercostal, Left PNINTERCOSTALL Retrocrual, Right PNRETROCRUALR Retrocrual, Left PNRETROCRUALL 3

15 Page 15 of 16 Post-Surgical M form Field # Field Name Oracle column Length Values Notes 169 Contralateral pleura PMETPLEURA 170 Contralateral lung PMETLUNG 171 Peritoneum PMETPERITONEUM 17 Intra-abdominal PMETINTRAABDOM 173 Bone PMETBONE 174 Liver parenchyma PMETLIVER 175 Brain PMETBRAIN 176 Other distant lymph nodes PMETOTHERDLN 177 Contralateral pleura - Biopsied or resected PMETPLEURABX 178 Contralateral lung - Biopsied or resected PMETLUNGBX 179 Peritoneum - Biopsied or resected PMETPERITONEUMBX 180 Intra-abdominal - Biopsied or resected PMETINTRAABDOMBX 181 Bone - Biopsied or resected PMETBONEBX 18 Liver parenchyma - Biopsied or resected PMETLIVERBX 183 Brain - Biopsied or resected PMETBRAINBX 184 Other distant lymph nodes - Biopsied or resected PMETOTHERDLNBX 185 Specify, Other distant sites PSPECIFYODSITES 00 alphanumeric alphanumeric 186 Other metastasis POTHERMETASTASIS No selection=null, Absent=ABSENT, Single=SINGLE, Multiple=MULT, Present=PRES, No data=nd No selection=null, Yes, resected=yres; Yes, biopsied, positive for malignancy=ybxpos; Yes, biopsied, negative for malignancy=ybxneg; No=N, No data=nd (optional additional information, when site of lesion is: SINGLE, MULT, or PRES) Document presence, number of lesions, clinical certainty factor, and whether biopsied/resected for any other sites of metastasis not listed above

16 Page 16 of 16 Follow Up form Oracle column Field # Field Name VARCHAR Values DDD: in (JAN, FEB, MAR, APR, MAY, JUN, 187 Date of Last Contact LCDATE DDMMMYYYY JUL, AUG, SEP, OCT, NOV, DEC) 188 Vital Status at Last Contact STATUSFU No selection=null, Alive=A, Dead=D, Lost to follow-up=l, No data=u